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Quality System Documentation: Strategies for Surviving an FDA Audit

Medical device manufacturers are one of the most regulated industry sectors in the world. The US Food and Drug Administration (FDA) oversees this industry and requires these manufacturers to implement quality system audits in accordance with their Quality System Regulation (QSR 21 CFR Part 820). Failure to do so can result in product quality and regulatory compliance issues as well as a lack of process improvements.

FDA AuditFDA inspectors follow Compliance Policy Guides (CPGs) that detail the steps for each type of inspection. When preparing for an FDA audit, it is important to understand which type of inspection is to be conducted. This will determine the length of time the inspectors will be at your facility and the type of documentation that you will need to present for their review.

Despite all their regulations, medical device manufacturers tend to fall short on the attention they give to making sure their quality system documentation is written with FDA reviews in mind. More than likely, FDA inspectors will include the documentation as part of their overall determination of the organization's compliance profile.

Are you prepared when the FDA shows up at your door? Are your Standard Operating Procedures (SOPs) up to date? Do your employees know how to interact with the FDA inspectors while they are on site? The following are a few valuable pointers for successfully surviving an FDA audit.

Pre-Inspection Strategies:

  • Plan ahead for the FDA inspection.
  • Follow all company SOPs for project completion, including creating and maintaining a master folder with the necessary documentation and associated review and approval sign-offs. Keep your SOP documentation up to date.
  • Refer to the CPGs to identify the scope and regulations associated with the pending inspection.
  • Be prepared to have the necessary resources to accommodate the number of FDA inspectors assigned and to manage the inspection itself.
  • Assign an inspection team and coordinator for the inspection, and spell out each team member’s roles and responsibilities.
  • Identify, in advance, how disputes with the FDA investigators will be handled. Follow FDA protocol.
  • Review past inspections and current procedures.
  • Identify the relevant documentation to be supplied for the inspection.
  • Stress the importance of making sure your inspection team members and other company personnel radiate a feeling of confidence that your company will exceed both the audit and the regulatory requirements. A good inspector can spot a lack of confidence, and this can impact the outcome of the audit.

Inspection Strategies:

  • Notify all employees that the FDA is on-site and that they should follow protocol when asked questions.
  • Assign a member of your inspection team to escort each FDA inspector at all times.
  • Require that all requests from an inspector go through your inspection team. Do not guess at an answer, but do ask for clarification when necessary. Asking questions during the course of the inspection can help resolve misunderstandings later on during the closeout meeting.
    “I don’t know the answer to your question, but I will locate someone who can answer it” is a valid response. Then, make sure the person that has the most knowledge of the issue is the one who answers the inspector’s question.
  • At the end of each day of the inspection, request a daily debriefing of the day’s findings. Inform upper management of all findings.
  • Do cooperate with the FDA inspectors, but do not try to hinder the progress of the inspector with idle conversations or non-relevant agendas.
  • Do not challenge the inspector’s understanding of the requirements and regulations. If challenges are warranted, make them in writing during the audit report’s resolution responses at the closeout meeting.
  • Avoid confrontation at all costs.
  • Have all records organized and available. Do not attempt to hide, misplace, or make existing documents unavailable. Be honest and forthcoming with the inspector. If an inspector senses false statements, this impression can set a negative tone for the rest of the audit.
  • Do not allow access to files. Give the inspector only those records specifically requested.
  • Review a requested record before sending it for inspection. Verify that the record is the one asked for. Check for any missing signatures, entries, or missing pages.
  • Once a record is reviewed, remove it from the inspection area.

Post-Inspection Strategies:

  • Utilize a closeout meeting at the conclusion of the FDA inspection to discuss the FDA inspector’s findings. The inspector will document any objectionable conditions observed during the course of the inspection in FDA Form 483.
  • Include all FDA inspectors and the company’s upper management in the meeting.
  • Read and discuss the contents of FDA Form 483 so that there is a full understanding of what the observations are and what they mean.

6 Tips for an Effective FDA Form 483 Response

Company management must respond to FDA Form 483 observations in writing within 15 business days of issuance.

  1. Include a commitment statement from your company’s upper management.

  2. Address each observation separately and note whether you agree or disagree with the observation.

  3. To challenge an observation, include all appropriate documentation that establishes the observation as invalid.

  4. Identify documentation of corrections that have already been completed.

  5. Include your corrective action plan for the remaining corrections along with the proposed dates of completion.
    - Address all affected products

    - Be complete
    - Be realistic with completion dates so that you can deliver what you promise

  6. Include a method of verification and/or monitoring for corrections.

Many of the FDA 483 observations and Warning Letter citations received by medical devices manufacturers during an FDA inspection are the result of poorly crafted and incomplete SOPs. Medical device manufacturers that utilize professional technical writers to develop their quality system documentation tend to perform significantly better during the FDA regulatory inspections, achieve reduced time to market from regulatory submissions, and increase staff effectiveness in developing required compliance documentation.

Wondering if your quality system is sufficiently documented? Download our Audit Ready Checklist:

DOWNLOAD Audit Ready Checklist

Have you participated in an FDA inspection for your company? Share your experiences in the comments below.


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