FDA Inspection Readiness Assessment Checklist
FDA inspection readiness is an ongoing state requiring systematic preparation. This readiness assessment identifies gaps before an inspection and ensures the site can present accurate, current compliance documentation.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Semi-Annual
- Estimated Time: 60-90 minutes
- Role: Quality Director / Regulatory Affairs Manager
- Total Items: 31
- Compliance: FDA 21 CFR Parts 210/211 cGMP Requirements, FDA Compliance Program Guidance Manual (CPGM) 7356.002 - Drug Manufacturing Inspections, FDA Pharmaceutical Quality System (PQS) Inspection Approach, EMA GMP Inspection Guidelines
Quality System Readiness
Assess overall quality system health.
- No critical or major open CAPAs, deviations, or OOS without resolution plan?
- Annual Product Quality Review (APQR) current for all commercial products?
- Quality trend data showing no adverse trends requiring escalation?
- Management reviews completed per ICH Q10 with documented outcomes?
- Quality metrics (right first time, OOS rate, CAPA timeliness) within acceptable targets?
Facility and Documentation Readiness
Verify facility and documentation are ready.
- Manufacturing areas clean, orderly, and presenting well to inspector?
- Site Master File (SMF) current and reflects actual operations?
- Batch records for recent batches readily retrievable?
- Process validation, equipment qualification, and cleaning validation current?
- All SOPs current, properly formatted, and easily retrievable?
Personnel Preparation
Prepare personnel for inspector interaction.
- Key personnel briefed on inspection procedures and their roles?
- Designated scribe to document all inspector questions and requests?
- Inspection escort trained to accompany inspector and ensure access?
- Response room (war room) set up with document request workflow?
- Personnel coached on answering only what is asked, not volunteering information?
Known FDA Focus Areas
Address current FDA inspection focus areas.
- Data integrity program robust with ALCOA+ compliance demonstrated?
- Process understanding and control strategy documented per ICH Q8/Q9/Q10?
- Microbiological controls current with no concerning EM trends?
- Supplier qualification for all critical materials current?
- Water system qualification and monitoring current?
Previous 483 and Warning Letter Status
Verify previous regulatory action items addressed.
- All previous FDA 483 observations from last inspection closed with verified effectiveness?
- All warning letter commitments met with documented evidence?
- Any import alert resolved or corrective action plan current?
- Voluntary corrective actions for known issues documented and in progress?
- Mock FDA inspection conducted within past 12 months?
Inspection Logistics
Verify logistical preparation for inspection.
- FDA badge verification and visitor sign-in procedure ready?
- Personnel know to request FDA investigator credentials (FDA-2289)?
- Regulatory attorney contact information available for real-time consultation?
- 483 response team identified with process for drafting EIR response?
- Chain of command for inspection notifications defined and communicated?
- Inspection readiness assessment report prepared and distributed to management?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Product Recall Readiness Checklist
- FDA GMP Inspection Readiness Audit Checklist
- Annual Product Quality Review (APQR) Preparation Checklist
- Pharmaceutical Product Complaint Handling Checklist
- Pharmaceutical Incoming Material Sampling and Testing Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
- Pharmaceutical Product Recall Readiness Checklist
- Pharmaceutical Daily Manufacturing Area Inspection Checklist
Related Regulatory Readiness Checklists
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Why Use This FDA Inspection Readiness Assessment Checklist?
This fda inspection readiness assessment checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for quality director / regulatory affairs manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: semi-annual.
Ensures compliance with FDA 21 CFR Parts 210/211 cGMP Requirements, FDA Compliance Program Guidance Manual (CPGM) 7356.002 - Drug Manufacturing Inspections, FDA Pharmaceutical Quality System (PQS) Inspection Approach, EMA GMP Inspection Guidelines. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the FDA Inspection Readiness Assessment Checklist cover?
This checklist covers 31 inspection items across 6 sections: Quality System Readiness, Facility and Documentation Readiness, Personnel Preparation, Known FDA Focus Areas, Previous 483 and Warning Letter Status, Inspection Logistics. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed semi-annual. Each completion takes approximately 60-90 minutes.
Who should use this FDA Inspection Readiness Assessment Checklist?
This checklist is designed for Quality Director / Regulatory Affairs Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.