language: Deutsch   Français   italiano   Español   Português   日本語   russian   arabic   norwegian   swedish   danish   Nederlands   finland   ireland   English  

Registrar Corp | U.S. FDA Regulations‎ complaint definition fda

FDA Regulations: Food and Beverages FDA Regulations: Medical Devices FDA Regulations: Drugs FDA Regulations: Cosmetics FDA Regulations: Electronicscomplaint definition fcab> FDA Regulations: Tobacco Registrar Corp assists businesses with U.S. FDA compliance. Registrar Corp is not affiliated with the U.S. FDA. div > .uk-panel'}" data-uk-grid-margin>

“The team members who supported us were quite professional, understanding and responsive. Highly recommend to others.”

– Primare International Ltd.

“The service is worth every dollar. Fast and efficient enrollment process. What should have taken 3-4 weeks they completed in one week. Highly recommended.”

– PharmaChem Technologies G.B. Ltd.

“They took the time to call a manufacturer that we were having issues retrieving the required info to process our request for a Prior Notice.”

– Landmark Nutrition

“We were very pleased with the professional approach and advice given throughout the whole mock visit.”

– Epigenetics Ltd

“I felt like I was in good hands and received responses quickly by informed staff. This was very important to our small company.”

– Shrubbers Smoked Salt & Seasonings

“A very professional service – prompt, customer-focused. We didn’t experience a single trouble collaborating with Registrar Corp.”

– Tentorium Ltd See More Reviews GLOBAL FDA Compliance SUPPORT View Locations div > .uk-panel'}" data-uk-grid-margin> Industries Quick Links Food and Beverages Medical Devices Drugs Cosmetics Electronics Tobacco Home About Resources Fees News Reviews Locations Contact Us Careers Associations Exhibitions Seminars Webinars Terms of Use Sitemap Choose Your Language Search Registrar Corp View Our Locations Choose Your Language Search Registrar Corp View Our Locations Choose Your Language English 中文 Español
complaint definition fda

moncler down jackets outlet
us digital millennium copyright act google
outlet moncler online italia COMPLAINTS AND RECALL HANDLING husna05 Download     Post to :   URL : Related Presentations :             Let's Connect Share   Add to   Flag Embed Email    Add to Channel

Copy embed code:

Embed: Flash   iPad Dynamic <h3 style="padding: 0px; margin: 3px;"><a href="" target="_blank" style="font:normal 18px,arial;">COMPLAINTS AND RECALL HANDLING</a></h3><object width="425" height="354" id="player"><param name="movie" value="" /><param name="allowFullScreenInteractive" value="true" /><param name="allowScriptAccess" value="always"/><embed src="" type="application/x-shockwave-flash" allowscriptaccess="always" allowFullScreenInteractive="true" width="425" height="354"></embed></object><div style="font-family: arial; font-style: normal; font-variant: normal; font-weight: normal;font-size: 11px; line-height: normal; font-size-adjust: none; font-stretch: normal;">More presentations from <a href="" target="_blank">HUSNA KANWAL QURESHI </a></div></div>" /> Copy

  WordPress Embed Customize Embed


URL: Copy

Thumbnail: <img id='imgThumbnail' src='' alt='' width='118' height='88' border='0' /></a>" /> Copy

  The presentation is successfully added In Your Favorites . Views: 4520   Category: Education         License:   All Rights Reserved   Like it ( 1 )     Dislike it ( 0 )   Added: September 08, 2011   This Presentation is Public   Favorites:  8

Presentation Description

No description available.

Comments Posting comment...  

By: Ggmfarma (68 month(s) ago)      

Hello dear can you please send me the soft copy of this presentation. I shall be thankful to you. Girish

Saving..... Post Reply Close Saving..... Edit Comment Close   Premium member Presentation Transcript

COMPLAINTS AND RECALLS HANDLING. : COMPLAINTS AND RECALLS HANDLING. PRESENTED BY, HUSNA KANWAL QURESHI. M.Pharm, 1st yr, 2 nd sem. UNDER THE GUIDANCE OF Dr. T. MAMATHA M.Pharm, Ph.D. QUALITY ASSURANCE. 1 COMPLAINT HANDLING: COMPLAINT HANDLING DEFINATION OF COMPLAINT: “Complaint is defined as statement that is something wrong or not good enough, which shows customer dissatisfaction about the company and the product”. Example: Complaint about packaging materials, Concerning about the product etc . 2 NEED FOR COMPLAINT HANDLING SYSTEM: NEED FOR COMPLAINT HANDLING SYSTEM It gives the company an opportunity to improve the quality of the product It is helpful to maintain cGMP It maintains committed relationship between the customer and company It is the regulatory obligation. 3 SOP on complaint handling: SOP on complaint handling OBJECTIVE: To lay out the procedure for investigation and reporting the market complaints. RESPONSIBILITY: The quality assurance manager along with manager of the complaint related department. PROCEDURE: Complaints shall be classified in following categories to facilitate investigation: Product quality complaints (non therapeutic). Packaging complaints (shortages and packaging error). Medical complaints (therapeutic problems). 4 Slide 5: 5 Slide 6: Time period for investigation after receipt of complaints: Product quality complaints – within 5 days. Packaging and quality complaints – within 10 days. Medical complaint – within 3 days. Complaint records shall be maintained at least one year after expiration date of medicines. Complaint records shall be reviewed and a monthly summary shall be prepared for the management. 6 Slide 7: PRODUCT NAME COMPLAINT CATEGORY Batch no . expiry date Packaging/ product quality/ medical. Packaging details: Name / address of the complainant: Complaint reported through: Complainant sample enclosed: yes / no Quality of sample enclosed: Investigation report Total quantity involved PCR received by On: Investigation done by: Action taken Conclusion: Confirmed/not confirmed PCR no: PCR approved by: recommended corrective actions 7 Product complaint data sheet: Product complaint data sheet Product complaint data sheet should have the following details: Serial number assigned to the complaints. Exact nature of the complaints. Name of the complainants. Address of the complainants. Date of complaint received. If verbal, name of the person who received the complaint. Name of the product, strength and batch number of the product. Reference to analytical record number. 8 Slide 9: Quantity involved in the complaint. Size of sample obtained from the complainant. Evaluation of complaint by QC department. Materials and records used to perform evaluation. Other possible effected materials, products and results of their investigation. Name and signature of the investigator(s) and date. Action taken by the company. Copy of reply sent to complainant. 9 Steps in handling of complaints: Steps in handling of complaints The proposed handling system is in compliance with the GMP Guidelines of EU, USA and Brazil and is presented in four steps: Receiving complaints. Technical investigation. Corrective actions/feedback to Customers. 4. Monthly reports/trend analysis. 10 Receiving complaints: Receiving complaints It is important to have open channels with with customers in order to receive their suggestions, doubts and complaints. Generally, these channels are toll-free numbers, e-mails, chat-rooms and P.O. boxes. The most flexible channels are toll-free numbers and chat-rooms. A person must be appointed in charge of receiving complaints and inputting them into appropriate investigation form that shall be addressed. 11 Slide 12: The investigation form must include: Information about the complainant: - Name - Address - phone no. - E mail Information about the drug product - Product name - Lot no - MFG & Exp date - Amount of the product with the problem. - Detailed description of the complaint. 12 Slide 13: customer Company's contact person QA complaint officer Make a complaint through toll free no., E-mails, P.O. Box Open the investigation, including information about the customer and about the complaint(product name, lot no., mfg & expiry date and complaint description.) Ask the customer to return the product for analysis. 13 Technical investigation: Technical investigation Upon receipt of the investigation form, the QA unit is able to start the investigation. It is divided into two phases: Documentation based investigation. Laboratory analysis. Documentation based investigation : The primary documentation to be reviewed consists of: Complaint files: This is constituted to check how many other complaints of the same nature had occurred to a specific lot and how they were handled. Batch records must be verified in order to see if there were any non-conformance during the production. 14 Laboratory analysis phase: Laboratory analysis phase It consists of requesting the Quality Control (QC) laboratory to analyze. Complaint samples. Retained samples. Complaint samples are the customer sample. Retained samples – the reserve samples representative of the lot manufactured (which were kept under appropriate conditions of temperature, humidity and light so that the drug product was not affected). The company elects a person in the QA unit to be in charge of technical investigation of each complaint, e.g. a Complaint Officer. 15 Slide 16: Documentation based Check complaint files for previous complaints of same nature. Check batch records. Laboratory analysis Analyze complained sample and retained sample. Send results to QA complaint officer 16 Slide 17: There are three possible conclusions, as follows: Confirmed complaints. Non confirmed complaints. Counterfeit/ tamper suspicion. CONFIRMED COMPLAINTS: When both complaint and retained samples showed out-of-specification (OOS) results or when only the complaint sample showed OOS results. Example : a single unexplained failure may be when one tablet is missing in the intact blister strip in the complaint sample, but no deviation was found in the retained samples or during the in-process controls and final QC analysis recorded in the batch record. 17 Slide 18: NON-CONFIRMED COMPLAINTS: When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results. OOS results in a complaint sample can be attributed to misuse or mishandling, when the drug product was not kept under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product could be affected. Example: Tablets of the complaint sample show a change in their appearance that is characteristic of a light, humidity or high temperature exposure. 18 Slide 19: COUNTERFEIT / TAMPER SUSPICION: When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product. Example: when packaging material is different from the original; an example of tampering is when the color of the drug product is completely different from the original or when any foreign substance was added to the product. 19 Slide 20: The Complaint Officer must also check if the complaint represents a serious and unexpected adverse drug experience. The Complaint Officer and the QA Manager must sign off the investigation form once the investigation is completed. 30 days is a reasonable time to conclude an investigation. Complaint files should be retained for at least 1 year after the expiry date of the lot. 20 CORRECTIVE ACTIONS AND FEEDBACK TO CUSTOMERS: CORRECTIVE ACTIONS AND FEEDBACK TO CUSTOMERS For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective Action and Preventive Action (CAPA) handling. If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory Affairs and Production Management must be established. Concerning non-confirmed complaints originating from misuse or inadequate handling of the drug product. The customer should receive a written response together with scientific information on the correct use and handling. 21 Contd … Slide 22: As feedback to the customer, the company must write a response letter to the complainant to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was confirmed. The customer should be sent a free replacement product together with the response letter, since the customer returned the product (the ‘complaint sample’) to the company for analysis and a quality problem was found. 22 Slide 23: 23 MONTHLY REPORTS AND TREND ANALYSIS: MONTHLY REPORTS AND TREND ANALYSIS Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints. The monthly reports must answer the following questions: How many complaints did the company receive in the period? How many were confirmed? How many were non-confirmed or were counterfeit/tamper suspicion? Graphic methods of displaying data are important adjuncts to data analysis and presentation. The report must be readily available mainly during GMP inspections. 24 Documentation final product complaint report: Documentation final product complaint report Nature of the complaint-------------------------- Date------------------ Complaint:------------------------- Originator of the complaint & title ---------------------------- Distribution contact person & title ---------------------------- Method of notification---------------------------- Name------------------------------------------------------ Phone No.------------------------------ P.O#-------- Date shipped-------------Invoice#------- Product name:----------------- Control no:---------- EXP date:---------------- Quantity involved--------------------- 25 Slide 26: Total quantity shipped---------------------------------------- Reason for complaint return request-------------------------- Complaint#------------ Product-------------------- Evaluation of complaints: 1.Physical characteristics------------------------- 2.Sign of deterioration ---------------------------- 3.Other observation-------------------------------- Quality control Findings: 1.Returned sample-------------------------- 2.Returned sample re assay--------------- 3. initial data------------------------------------- 26 Slide 27: 4.Quality control comments & suggestions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Quality control-------------------,Date-------------------- Complaint#____________________________________ Product_______________________________________ Packaging/Labeling/Inserts evaluation_______________________________________________________________________________________________________________________________ Remarks___________________________________________________________________________________ 27 Slide 28: Resultant action taken: 1.Method,Date of customer notification & authorized action_____________________________________________________________________________________ 2.Comments_____________________________________________________________________________________________________________________________ 3.Completion date for action taken _______________ 4.Quality assurance evaluation _______________________________________________________________________________________________________________________________ 28 Customer complaint record book: Customer complaint record book Report no. Date received Product name Received by Product lot no. Date investigation started Date investigation ended 29 RECALL HANDLING: RECALL HANDLING ‘‘Recall’’ means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. The main objectives of this recall plan are: Stop the distribution and sale of the affected product. Effectively notify Management, customers and regulatory authority. Efficiently remove the affected product from the marketplace, warehouse and/or distribution areas. Dispose and Conduct a root cause analysis and report the effectiveness and outcome of the recall. Implement a corrective action plan to prevent another recall . 30 SOP on recall: SOP on recall RESPONSIBILITY: General manager / vice president: (QA/QC, Regulatory) General Manager: manufacturing. In case of adverse event a committee evaluates the crisis. It consists of following individuals: GM/V.P/QA/QC, Regulatory GM Manufacturing GM, Formulation and Development Medical advisor Vice president - Marketing Vice president – International Marketing Vice president – Technical Operations 31 Slide 32: PROCEDURE: Any employee becoming aware of such medicine should immediately notify to higher authorities. Immediately quarantine existing in-house of relevant medicine . Record the following information : The product name, strength, packs size, batch no., mfg and expiry date. The total number of units released for sale. Date on which distribution commenced. Total number of units distributed. Number of units still in stock. Nature of reported violation. In the light of above information higher officials evaluates the health hazard presented by the violation medicine and documents it on “ medicine recall control document”. 32 Slide 33: INDIAN PHARMACEUTICALS LIMITED Medicine recall control document Product information: Manufacturer --------------------------------------------------------------- 2. Product name--------------------------------------------------------------- Strength----------------------------------------------------------------------- Pack size-------------------------------------------------------------------- batch number --------------------------------------------------------------- total number of units originally released for sale: _________ Date of which distribution commenced: ______________ Total number of units distributed: _____________________ Number of units still in stock: At factory With stockiest (s) 10. The nature of the reported violation: __________________________________________________ 33 Slide 34: Formulating a proposed recall strategy . It specifies the nature of communication to be used (phone, fax, telegram, letters, telemail, etc) as well as the level in the distribution chain to which recall is extended.(wholesalers, retailers, public, etc). Relevant records shall be submitted to regulatory authorities with proposed plan of action. INDIAN PHARMACEUTICALS LIMITED Medicine recall control document 3. RECALL STRATEGY 3.1. Nature of communication (phone, fax, telegraphs, letters, news papers, etc.) __________________________________________________ __________________________________________________ Depth of recall: (Wholesalers, retailers, general public) __________________________________________________ 34 Slide 35: The GM, QA/QC Regulatory or GM manufacturing implements recall without delay. They also prepare an interim reconciliation report after 30 days and submit a copy to concerned authorities. After that prepares a final reconciliation report after 90 days and submits a copy for verification of the success of recall. NAME OF THE DISTRIBUTED QUANTITY DISTRIBUTED QUANTITY RETURNED QUANTITY ACCOUNTED TOTAL 35 Slide 36: Signature of GM, QA/QC Regulatory G.M. manufacturing should be taken. Steps should betaken to prevent the re-occurrence. Prior to completion of recall the following points should be considered: Method of destruction of the product . A designed area to receive returned medicines. Inventory of medicine. Destruction authorization. The recall will be terminated when the GM, QA/QC Regulatory or GM manufacturing are assured that recall has been completed reasonably and a “medicine record status report” is completed. 36 Slide 37: INDIAN PHARMACEUTICALS LIMITED MEDICINE RECALL OR WITHDRAWAL, PROCEDURE STATUS REPORT Date: ________ product: ___________ Strength:____________ Pack size: ____________ ________ Nature of defect: ____________________________________ Reason for recall: _____________________________________ Indication of health risk or any other reason: ________________ Reported clinical problems: ______________________________ Method of communication to users: Method Action Date Target Group Number Phone Letter Telegram TV Radio, Press etc. 37 Slide 38: GM, QA/QC Regulatory or GM manufacturing shall prepare a “ Standardized recall letter” and “press statement”. INDIAN PHARMACEUTICALS LIMITED STANDARD RECALL LETTER Dear customer: It has come to our notice (product name) _______________ having batch number ______________ or has shown ________ please refrain from prescribing or dispensing any of this batch number and return all your stock of this batch number to our office at: __________________________________________ All returned stock or this batch number will be replaced as free of charge. We apologies for any inconvenience caused to you and thank you for your co-operation. Yours faithfully, G.M. QA/QC Regulatory 38 Slide 39: After the authorization by GM, QA/QC Regulatory or GM manufacturing, the recalled material along with stock in hand shall be destroyed and that should be recorded . RECALL CLASSIFICATION: FDA classified the product recall depending on the health hazard caused by the product . Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 39 Slide 40: RECALL POLICY: Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the FDA. Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of FDA. Recall is generally more appropriate and affords better protection for consumers. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration. 40 Slide 41: HEALTH HAZARD EVALUATION: An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration. It involves the assessment of hazards to various segments of the population, degree of seriousness, likelihood of occurrence, consequences etc. RECALL TEAM: A recall coordinator is to be appointed and members of a recall team identified from the various functional areas. All members must ensure that all procedures are carried out effectively and efficiently. The team should receive appropriate training. The Recall Management Team list shall be updated at least four times a year. 41 Slide 42: NAME ALTERNATE PERSON BUSINESS PHONE AFTER HOURS PHONE RESPONSIBILITIES DURING RECALL Chief Executive Officer Production Manager Decision Making Media Communication Contacting Accounts CFIA,/ Health Departments Contact Obtaining Legal Counsel Quality Assurance Manager Production Manager Quality Assurance / Technical Advisory Complaint Investigation CFIA / Health Departments Contact 42 Slide 43: RECALL STRATEGY: A recall strategy that takes into account the following factors : ( i ) Results of health hazard evaluation. (ii) Ease in identifying the product. (iii) Degree to which the product's deficiency is obvious to the consumer or user. (iv) Degree to which the product remains unused in the market-place. (v) Continued availability of essential products. 43 Slide 44: Elements of a recall strategy: Depth of recall. Public warning . Effectiveness checks: Level A--100 percent of the total number of consignees to be contacted. Level B- greater that 10 percent and less than 100 percent of the total number of consignees. Level C--10 percent of the total number of consignees to be contacted. Level D--2 percent of the total number of consignees to be contacted. Level E--No effectiveness checks . 44 Slide 45: TERMINATION OF RECALL: A recall will be terminated when the FDA is confident that product has been removed from market in accordance with recall strategy. FDA’s written notice to the regulatee is the real termination. 45 Slide 46: PRODUCT RECALL CHART 46 Contd …. Slide 47: 47 References: References 1.Us 48 Food &drug administration.21 code of federal regulation-part 211.198. 2. Current good manufacturing practices of pharmaceuticals - Manohar . A . Potdar. 3. How to practice GMP By P.P. Sharma 4. Validation in pharmaceutical industry by P.P. Sharma. 5. Recall Manual (,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=1358&bih=566) 48 References: References 6. Complaint Handling in Pharmaceutical Companies Glaucia Karime Braga*; Faculty of Pharmaceutical Sciences, University of Sao Paulo, Brazil. 7. WHO technical reports series, No. 908, 2011. 8. Good Manufacturing Practices for pharmaceuticals – A Plan for total Quality control from manufacture to consumer 5th edition - Sidney H. Willig. 9. 10. .com 49 Slide 50: 50

View More Presentations Handling Difficult People by JOJO VITO By: INTRASPEC STRESS By: shubham113422 COMPLAINT HANDLING ,PRODUCT RECALL,RETENTION ,DISTRIBUTION RECORDS By: susena COMPLAINTS AND RECALLS By: mallipharm Complaints and recalls By: vinodmaheshwari88 Complaints and recalls BY RAHUL By: dums Complaints and Recalls By: Kandarp_Trivedi FS_3.7_Handling Customer Complaints By: savvan Acorn Stairlifts Complaints Vs. Stannah Complaints By: stairliftreview Tips from the Pros – Handling Customer Complaints By: DialogueMarketing Tags Recalls Complaints *You can't enter more than 5 tags.

Enter one or more tags separated by comma or enter. Numeric tags are not allowed.

Update | Close Presentation Statistics loading..... loading..... Channel Statistics

Included in these Channels:

You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.

FDA warning letter highlights obligations of private label distributors 1 comment By Stephen DANIELLS Stephen DANIELLS , 10-May-2013 2013-05-10T00:00:00Z Last updated on 10-May-2013 at 19:14 GMT 2013-05-10T19:14:51Z

Related tags: Private label distributors , FDA , Warning letter , Contract manufacturers , AHPA , Justin Prochnow

A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.

The American Herbal Products Association (AHPA) said: “Companies that use contract manufacturers, packagers, or labelers should read this letter” .

In the warning letter, dated April 26, 2013, FDA writes: “As a distributor that contracts with other manufacturers to manufacture, package or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)].

“Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers.

“As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.”

Please click here to read the warning letter to Pristine Bay, L.L.C. d.b.a. Vianda, and its owner Charles J. Kubicki .

The obligations of private label distributors

In his weekly Lawguy’s Corner blog, Justin J. Prochnow, shareholder at lawfirm Greenberg Traurig, LLP in Denver, said: “I have previously identified warning letters in which FDA has reiterated the obligations of private label distributors to ensure that the cGMPs are followed, even if the private label distributors do not perform any manufacturing duties.

“While other letters have pointed out the obligations of private label distributors, FDA, in an April 26, 2013 letter to Pristine Bay LLC dba Vianda, goes to greater lengths to emphasize the private label distributors’ obligations.”

If you use a contract manufacturer, read this letter

“FDA has for some time taken the position that companies using contract manufacturers have substantial cGMP responsibilities,” stated AHPA in a legal alert. “To support this proposition, FDA cites from the preamble to the cGMP regulations.

“In this warning letter, FDA goes further and cites the strict criminal liability nature of violations of the Federal Food, Drug, and Cosmetic Act. Companies that use contract manufacturers, packagers, or labelers should read this letter.”

The firm that contracts with other firms […] is responsible […] regardless of who actually performs the dietary supplement CGMP operations

Prochnow identified key passages from the warning letter to note: “Although, your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements.”

FDA then recommended the company to see United States v. Dotterweich, 320 U.S. 277, 284 (1983), which explains that an offense can be committed under the Act by anyone who has a “responsible share in the furtherance of the transaction which the statute outlaws”.

The Agency also points the company to United States v. Park, 421 U.S. 658, 672 (1975), which holds that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act.

The warning letter continues: “In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g), 331(a)).

“Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.”

Strict compliance

“There is no question that FDA has been and is going to continue to conduct inspections with a particular focus on the principles set forth above,” said Prochnow.

“Dr. Daniel Fabricant reinforced this at Supply Side Marketplace, indicating that the assurance of strict compliance with the dietary supplement cGMPs continues to be a very high priority issue for FDA.”