Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate its commitment to patient safety and regulatory compliance. By staying prepared, transparent, and responsive, you can navigate the audit process successfully, and strengthen your company’s reputation within the industry.
Upon receiving an audit notice, the first step is simple: Remain calm! Alert key stakeholders within your organization, including regulatory affairs, quality control, legal, and senior management. Effective communication is essential to ensure that everyone is on the same page and can contribute their expertise to the audit process.
Step 1: Take a deep breath. Respond to the FDA, and let them know you will be available to support their inspection of your facility and introduce your management representative.
Step 2: Make sure all personnel are available for the inspection. You will need to make sure the management representative is available at all times, as well as a dedicated person to take notes (as it can be difficult to have technical discussions with FDA and take notes at the same time). Executive management should also make themselves available at the opening meeting and as requested afterwards. Process leads (production supervisor, head of design, etc.) should be available as requested, but do not need to attend consistently throughout the audit. Some processes may demand pulling process leads away from their regular duties for longer interview times by FDA – usually FDA is amicable to shift certain processes to allow work to continue with as minimal disruptions as possible. That being said, it is always best to fulfill FDA requests to the best of your abilities.
Step 3: You cannot repair an entire QMS on short-notice. Take time to plan for areas of concern based around key FDA inspection processes:
- CAPA (and complaints). Ensure CAPAs and complaints are up to date with most recent activity. For CAPAs that have been open for > 30 days, provide a justification as to why the CAPA has remained open. Update the CAPA and complaint log. Ensure all complaints have justification as to why Medical Device Reports were not submitted (based on criteria in 21 CFR Part 803).
- Design Control. Ensure your traceability matrix is up to date and that all documents referenced within are compiled and prepared for FDA review. If you have had design changes since 510(k) clearance or the previous inspection (if applicable) prepare these design change records, including justifications for not submitting a new 510(k) for each change (based on FDA letter to file guidance)
- Management Responsibilities (resources, training, internal audit, management review). Prepare the training records for employees, the internal audit schedule/CAPAs which were initiated after the audit (not the report itself), and the management review agenda/attendance list (not meeting minutes).
- Production Controls. Ensure the equipment, calibration, and environmental monitoring logs are up to date (as applicable). Ensure DMRs are compiled. Ensure DHRs are readily accessible. This includes sterilization records (which are a high concern for FDA). Sterilization records should include the validation plan/protocol, report, and evidence of sterilization release records for each device that is sterilized (typically a sterilizer load release report will include multiple lots of devices).
- Document and Record Controls. Ensure the controlled document master list is up to date. Verify all document change orders are fully approved and implemented. Ensure training (or justification for why training isn’t appropriate) is provided to all relevant employees (per the training matrix) on the most current version of each document they need to be trained to. Ensure records are signed off as you compile them to address the other target processes.
- Compile these records from Step 3 going as far back as the previous FDA inspection. Note – ISO auditors only go back to the last audit, which is an annual cadence. FDA inspections go back to the last inspection, which may be 3-7 years in some instances. If you have never had an FDA inspection, records will go back to the date you began commercialization.
- If you have had a prior FDA inspection, create a inspection remediation folder which contains the following documents:
- Previous inspection report
- CAPAs opened to address findings within the previously issued form-483.
- All evidence of CAPA resolution
- All communication between your organization and FDA showing the evidence was provided and accepted by FDA compliance officers.
- FDA has to verify jurisdiction via evidence of interstate commerce. Prepare some customer orders with the corresponding distribution records. Distribution records should include the tracking number and a record of the tracking number showing the package was delivered. Prepare these records for 3-5 different orders prior to the inspection.
- Prepare your employees for communicating with the FDA. In these instances, it is best to:
- Answer the question as asked by FDA, but do not provide additional information – if the FDA needs that additional information, they will ask. If a question is unclear, request clarification.
- Lean on your procedures. It’s okay to tell FDA, “Whenever I am unsure, I reference the procedure”.
- Ensure that all employees know where to access QMS procedures relevant to them. This includes the Quality Policy for your organization.
- If asked how you would respond to a certain situation, it is okay to respond with “I would check with my supervisor”.
Once the audit is complete, conduct a thorough review of the audit process itself. Identify opportunities for improvement in your internal processes, documentation, and overall quality management system. Use the audit experience as a catalyst for ongoing enhancement of your company’s regulatory compliance practices.
If you need help navigating a FDA audit, look to Rook Quality Systems: We’ve been supporting our clients during FDA inspections for over a decade, and our experts can be available around-the-clock to address any urgent compliance concerns or inquiries during the inspection. We’re here when you need us.