FDA WARNING LETTERS. FDA s Warning Letter Process and How to Respond

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1 FDA WARNING LETTERS 1 FDA s Warning Letter Process and How to Respond Jessica L. Kocian Compliance Officer Compliance Branch Division of Human and Animal Food Operations West 6 Office of Regulatory Affairs (ORA) U.S. Food and Drug Administration FDA Warning Letters 1

2 Disclaimer The views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the U.S. Food and Drug Administration. 3 FDA Warning Letters 2

3 What is a Warning Letter? RPM Advisory Action Regulatory Procedures Manual Chapter 4 Issued to achieve voluntary compliance Establish prior notice Based on expectation that most individuals and firms will voluntarily comply with the law 6 FDA Warning Letters 3

4 What is a Warning Letter? RPM Informal and advisory Communicates Agency s position but does not commit FDA to taking enforcement action Seizure, injunction, civil money penalties, prosecution, administrative detention, recall FDA does not consider Warning Letters to be final agency action 7 What is a Warning Letter? RPM FDA is not legally obligated to warn individuals or firms that they are in violation prior to taking an enforcement action There are situations where the agency may take enforcement action without necessarily issuing a Warning Letter Example: violation presents a reasonable probability of injury or death 8 FDA Warning Letters 4

5 Warning Letter Format RPM Titled: WARNING LETTER Addressed to highest known official in the corporation that includes the inspected facility Copy sent to highest known official at the inspected facility Dates of the inspection Description of the violations and citation of the section of law and regulations violated 9 Warning Letter Format RPM Acknowledges corrections promised Firm s written response to a Form FDA 483, Inspectional Observations Request for correction and a written response (usually 15 working days) Warning statement Signed by the District Director, Division Director, or higher agency official 10 FDA Warning Letters 5

6 Warning Letter Process FMD-86 FDA conducts an inspection which may include issuance of Form FDA 483 Investigator compiles evidence and writes report Supervisor reviews report Field Management Directive 86: Establishment Inspection Report Conclusions and Decisions 11 Warning Letter Process FMD-86 Supervisor determines significant objectionable conditions or practices warrant a Warning Letter, enters a recommendation of Official Action Indicated (OAI) Case referred to Compliance Branch Assigned a Compliance Officer 12 FDA Warning Letters 6

7 Warning Letter Process FMD-86; RPM Compliance Officer reviews the report, evidence, firm s written response to Form FDA 483, sample results, firm history and previous reports Consider FDA guidance documents: Compliance Program Manual (CPGM), Compliance Policy Guides (CPG), other FDA guidance on 13 Warning Letter Process RPM General Considerations: Evidence shows violation of law or regulations and failure to achieve correction may results in agency consideration of enforcement action Violations are of regulatory significance and is consistent with agency policy Reasonable expectation that responsible firm and persons will take prompt corrective action 14 FDA Warning Letters 7

8 Warning Letter Process RPM Ongoing or Promised Corrective Actions Generally do not preclude issuance of a Warning Letter Consider firm s compliance history, nature of violation, risk, overall adequacy of firm s corrective action, documentation of corrective action, appropriate timeframe, sustained compliance Completed Corrective Actions Should not be issued if corrective actions adequate and violations for Warning Letter are corrected Exception may be necessary 15 Warning Letter Process RPM 4-1-4; Exhibit 4-1 Warning Letter is drafted May require FDA Center concurrence May require Office of Chief Counsel concurrence Signed by District Director, Division Director, or higher agency official Final classification of inspection (OAI) 16 FDA Warning Letters 8

9 Cyber Warning Letters FDA may review firm s websites to see if promoting products with drug claims These may issue without FDA inspection 17 Posting to FDA.gov All redacted Warning Letters are posted to FDA s website: Actions/WarningLetters/default.htm Some information may be redacted in accordance with Freedom of Information Act (FOIA) 18 FDA Warning Letters 9

10 FDA Warning Letters 10

11 Posting to FDA.gov Remains on website permanently Recipient may request that their response be posted on FDA s website Agency will post but reserves right not to post certain responses i.e. when posting likely would mislead public about safety or efficacy of a regulated product Response is redacted prior to posting 22 FDA Warning Letters 11

12 Responding to Warning Letter Firm usually has 15 working days to respond in writing Response should include: Specific steps taken to correct the violations How to prevent future recurrence of violations Documentation necessary to show correction achieved If not fully completed, reason for delay and timeframe for corrections 23 FDA Review of Response RPM Division Compliance Branch will review firm s response to Warning Letter Should acknowledge in writing receipt of the Warning Letter response May include comments or concerns regarding adequacy of response May ask for additional information 24 FDA Warning Letters 12

13 Follow-up Inspection RPM 4-1-8; FMD-86 ORA s goal is for follow-up inspections to be conducted within 6 months after an OAI classification is finalized and action taken (FMD-86) Inspection verifies corrections to Warning Letter violations are implemented, adequate, and sustained 25 Follow-up Inspection RPM Compliance Branch reviews inspection report and any written response to the inspection by the firm Determines whether violations from the Warning Letter have been corrected Determines whether a Warning Letter Closeout Letter is appropriate 26 FDA Warning Letters 13

14 Warning Letter Close-out Letter RPM Will not be issued based on representations that some action will or has been taken Corrections must actually have been made and verified by FDA Does not relieve the recipient from responsibility for sustained compliance WLCO Letter posted to FDA.gov 27 FDA Warning Letters 14

15 Warning Letter Close-out Letter RPM Conditions to be met: Firm replied to Warning Letter with sufficient information to demonstrate violations have been adequately corrected; or Follow-up inspection shows implementation of corrective actions was adequate; or based on other verified, appropriate and reliable information, FDA determines a follow-up inspection is not needed; and Follow-up inspection (or other appropriate and reliable information) does not reveal other significant violations 29 Closing Warning Letter Case If WLCO Letter received, indication that case is closed If no WLCO Letter is received, case may still be considered closed under Title 21 Code of Federal Regulations (CFR) Part 20.64(d)(3) If no WLCO letter is received, case may still be considered open 30 FDA Warning Letters 15

16 How to Respond? Submit a response within timeframe specified Submit documentation supporting corrective actions Photographs Training Records SOPs Consultant report Revised labels and labeling Records sanitation records, HACCP plan and records Other documents 31 How to Respond? Include how firm will prevent violations from recurring in the future Sustainable corrections versus quick fixes Systemic considerations Has a root cause been identified? Has the root cause been addressed? Provide a timeline if corrections are delayed 32 FDA Warning Letters 16

17 How to Respond? Take comments received by FDA after review of response into serious consideration Determine whether outside assistance or expertise needed Be prepared for a follow-up inspection 33 Avoiding a Warning Letter Be in compliance Be aware of regulations that apply to facility and products Be aware of guidance documents Review other Warning Letters issued Stay up to date on compliance dates for new regulations Respond to inspectional findings in writing within 15 working days 34 FDA Warning Letters 17

18 Questions? FDA Warning Letters 18

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