Warning Letter Success StoryRe-establishing Your Credibility with the FDASUCCESSNext Exit
What is a Warning Letter?• The term “warning” literally means “a threat orsign of impending danger”; so you canunderstand why people have real concern withregard to the letter from the government stating“Warning”.• FDA: "...a correspondence that notifiesregulated industry about violations that FDA hasdocumented during its inspections orinvestigations. Typically, a Warning Letternotifies a responsible individual or firm that theAgency considers one or more products,practices, processes, or other activities to be inviolation of the Federal Food, Drug, andCosmetic Act (the Act), its implementingregulations and other federal statutes.
Our story begins…Compliance Insight was contacted by a medical devicemanufacturing company to help with a warning letter for anumber of significant GMP inspectional observations. Thefollowing steps were taken to establish regulatorycompliance:• Prepared warning letter response with a time line tocomplete each observation.• Provided periodic status updates to the FDA for the issuesstated in the warning letter and notification of theremedial action taken in each case.• Trained all the employees on Quality System Regulations.• Established Quality Systems at all levels of theorganization.• Prepared and implemented procedures as per QualitySystem Regulations.• Communicated with the FDA on a continual basis toensure that all pending issues were addressedsatisfactorily.
What we did to help!• We were there to help the company find theright solutions for their particular needs• Trained everyone• Oversight of activities• Communicated with the FDA• We were part of the company!!!• In the end, the FDA re-inspected the firm andthey passed with flying colors!!! All issues wereresolved!
The Response:Re-establishing CredibilityOnce observations are given, particularly criticalor major points, the firm has a limited amount oftime to respond. 15 days!!!Work to put a time frame around the response inplace and adhere to it diligently.This is the firms chance to re-establish credibilitywith the FDA.Visit our website for some tips on how to writethe response, format recommendations andexamples: www.Compliance-Insight.com
An approach for formulating aresponseEvaluate the current state of compliance in light of theaudit observation. If possible, indicate what is compliant.Identify the root cause of the issue as appropriate.Understand how the firm will resolve the issue systemically.Review prior commitments. Are any issues a repeatobservation or a repeat observation for the same typesystem issue? This is critical to know and understand. Ifyou have made a commitment in the past regarding anobservation but the corrective actions were notimplemented or did not resolve the issue, the inspectingbody will evaluate the current observations in a morecritical light. Repeat observations also greatly increase thelikelihood of further regulatory actions.