The Food and Drug Administration can inspect a facility for many reasons: a routine planned inspection, a survey, or a response to a reported problem. Knowing how to prepare for an FDA inspection means having every document ready for review and every employee able to talk with the inspector. Planning ahead helps the inspection run smoothly and lowers the chance of follow-up work or a Form FDA 483 listing inspectional observations.
Why does FDA inspection readiness matter?
FDA inspections can be stressful, and misunderstanding the process can lead to poor outcomes. An inspection can come at any time, often with short notice, so being prepared is critical. The steps below will help you get ready the next time you are notified.
Which documents should you have ready?
1. Identify and prepare all documents the FDA is likely to review. These may include:
- Key procedures for document and change control, complaint handling, CAPA and similar processes
- An overview of the quality system, including a quality manual if you have one
- Organizational charts
- Job descriptions, position descriptions, training methods and training records
- Device inventories
- Responsibility matrices
If any records are stored offsite, retrieve them and make them available for inspection.
2. Once the inspection is scheduled, find out the inspector’s name and consider filing a Freedom of Information (FOI) request. This can show whether the inspector has a background in GLP, GMP or GCP inspections. Also look at the kinds of FDA 483 observations the inspector has issued before and what they are likely to focus on.
How should you prepare employees?
3. Train employees on how to interact with FDA inspectors. Confirm that they have been trained for their current roles and that the training is documented. This reduces the risk of wrong answers and unnecessary information.
4. Run mock FDA inspections to rehearse and to measure readiness. These are often done internally, but an independent expert can recreate a real inspection more accurately.
5. Learn how the FDA inspects. Review its procedures and manuals, FDA guidance documents, past warning letters, earlier 483s and prior establishment inspection reports.
How do you organize the inspection team and room?
6. Put together a team to manage the inspection and give each member a clear role. Set up an audit room for the inspection. The inspector will interview staff and ask for many documents. Provide only the documents requested, not every study or essential file. Keep confidential records, including clinical and research records, out of the room.
If possible, place the review area somewhere quiet and away from workspaces and clinical areas, so inspectors do not overhear confidential information. Make sure the inspection host can stay with the inspectors in the review area at all times. A dedicated copier and printer, if available, keeps things moving, since inspectors may copy important papers or source documents they review.
7. Assign a knowledgeable representative, such as the plant or production manager, to accompany the investigator at all times. The escort handles all FDA requests and makes sure questions are answered fully and honestly.
How to answer inspector questions
- Listen to the question and answer only that question.
- If you do not know, defer to a colleague who does.
- Where possible, support answers with documents already provided.
- Stop once the question is fully answered. Silence after an answer is fine.
If you have doubts about anything the investigator is doing, ask.
What happens at the end of an FDA inspection?
At the close of the inspection, the investigator discusses significant findings and concerns with management. The investigator then leaves a written list of conditions or practices that, in their opinion, are objectionable. This list of inspectional observations is the FDA Form 483.
The FDA representative usually does not prescribe specific corrective steps, so management can use the Form 483 as a guide for corrective action. Your company can and should respond to the 483 during the closing discussion. Corrections or procedure changes made promptly, while the investigator is still there, show your concern and willingness to fix problems.
Related Blogs
9 Ways to Improve Employee Engagement and Productivity at Work
Transforming Payments: Introducing FedNow - The Future of Real-Time Transactions
Related Industries
FDA Compliance
Medical Devices
Clinical Research
Audit Webinar
HR Compliance
Banking and Finance
Hospital and Healthcare
Packaging and Labeling
Accounting, Payroll and Taxation
Food and beverages
Software
Miscellaneous
Pharmaceutical