Are you prepared for an FDA Inspection?
01 December 2017
Perform an internal Quality Audit
Internal quality audits help you to identify possible compliance problems and areas of concern, so you can adjust procedures and processes as required. An internal auditing program is ideal for ensuring that individual processes and your entire quality system does meet FDA process validation and compliance requirements.
Review Quality Procedures and Practices
The FDA inspector or officer will review your quality system, so familiarize yourself with applicable regulations, guidance documents and manuals. It isn’t enough to draft procedures that comply with FDA approval requirements. Ensure that procedures align with the company’s manufacturing process and practices, since both will be reviewed and audited during the inspection.
Also review past warning letters and citations, non-conformation reports, batch reports, clinical trial and product performance reports, risk assessments, training records and operating procedures. Compliance to FDA 21 CFR Part 820 is required for medical device companies seeking FDA approval in the U.S., so make sure you have everything needed for demonstrating regulatory compliance.
Ensure Your Team is Fully Prepared
FDA inspections are stressful, even when you’re prepared for them. Consider, looking into training courses for FDA process validation, quality assurance and industry best practices. Use mock inspections to make sure everyone knows what to expect and how to handle it.
Define roles and responsibilities for employees who will be involved in the inspection, and coach them on answering questions directly and responding specifically to what is asked.
Don’t Panic Before an Inspection
A little panic is normal, but keep it under control:
- Inform everyone about the pending inspection, but continue with routine production and regular business practices instead of changing them before the inspector arrives.
- Designate an area for interviews, data collection and evaluation. Also assign a specific team member to accompany the inspector/officer always during their tour of the premises.
- When the inspector points out issues that need correction, avoid trying to fix them during the inspection.
- If you don’t understand the inspector’s comments, ask for clarification instead of trying to guess at what they mean.
- If you don’t agree with observations, avoid being argumentative or defensive. You must follow FDA rules whether you agree with them or not, but calmly state your case with supporting objective evidence if possible.
- Be honest while answering questions, and if you don’t know the answer, admit it instead of making up a response. Provide supporting documentation and records for all your responses.