FDA inspection readiness checklist

Begin by notifying your leadership team and assembling your cross-functional inspection response team. Customize and review this checklist thoroughly, focusing on high-risk areas first. Gather and organize required documentation, ensure facility cleanliness, and conduct a mock inspection if time permits. Most importantly, prepare your staff through clear communication about roles and expectations.

Prepare a well-organized system containing your quality manual, standard operating procedures, validation records, training documentation, batch records, and investigation reports. Also include complaint handling procedures, CAPA documentation, equipment calibration records, and supplier qualification information. Having these documents readily accessible demonstrates your commitment to transparency and compliance.

Treat each “NO” response as an opportunity for improvement rather than a failure. Document the gap, assess its regulatory risk level, and develop a corrective action plan with clear ownership and timelines. Implement solutions promptly, verify their effectiveness, and update your procedures to prevent recurrence. This proactive approach transforms weaknesses into compliance strengths.

Customize the checklist by adding industry-specific requirements from relevant guidance documents and regulations. For pharmaceutical companies, incorporate elements from 21 CFR Parts 210/211. Medical device manufacturers should add 21 CFR Part 820 requirements. Food producers should include FSMA provisions. Review recent 483s in your industry to identify trending concerns to add.