Understanding FDA inspection records is critical for manufacturers. When the FDA walks into your facility, they don’t get to see everything. There are clear rules about what’s accessible and what’s protected. Get this wrong, and you could face delays, fines, or worse. Let’s break down exactly what inspectors can and can’t see, and how to prepare.
What FDA Inspectors Can and Can’t Access
Current Good Manufacturing Practices (CGMP) are regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards. The FDA checks these during inspections, but not all records are open for review. For example, internal quality assurance audits-done as part of a company’s written quality program-are generally off-limits. This policy comes from Compliance Policy Guide Section 130.300 a guidance document that protects candid internal audits from FDA review, issued in 1996. Dr. Jane Axelrad, former FDA Deputy Center Director for Policy, explained this in a 2024 webinar: "This creates a safe space for companies to conduct meaningful internal audits without fear of regulatory repercussions for candid findings." However, if an audit relates to a specific product failure or deviation investigation, those records must be shared. Under 21 CFR 211.180 pharmaceutical record retention rule requiring documents to be kept for at least one year after a drug’s expiration date, companies must retain production records, validation data, and quality control investigations. Medical device manufacturers follow 21 CFR 820.180 requiring quality system records to be kept for device lifespan plus two years.
The Form FDA 483 Process
Form FDA 483 the official document listing inspectional observations from FDA reviews is handed out at the end of an inspection. Companies have exactly 15 business days to respond. This isn’t just paperwork-it’s a critical step. Data from FDA’s 2024 Compliance Metrics Report shows companies following recommended root cause analysis methods close 89% of Form 483 issues within six months. Those using simpler approaches only manage 62%. Merck QA Manager David Chen shared in a Biophorum forum thread: "The 15-day window creates serious pressure during busy production periods." Pfizer’s Susan Martinez added: "Many quality teams over-disclose records because they’re unsure what’s protected. Our internal survey found 63% of cases included unnecessary audit reports." Inspectors use FDA Form 482 the Notice of Inspection document that formally starts an inspection to announce their visit. This form is issued before any records are reviewed, giving companies time to prepare. But don’t confuse this with Form 483-it’s just the start of the process.
Remote Regulatory Assessments (RRAs)
Since FDA finalized Remote Regulatory Assessments (RRAs) virtual evaluations that may substitute for physical inspections in certain circumstances guidance in July 2025, companies have new options. RRAs let inspectors review digital records without visiting the site. They’re not formal inspections, so they don’t generate Form 483 observations. In the first half of 2025, RRAs accounted for only 8% of total inspections, but adoption is growing fast. FDA’s 2025 RRA Impact Assessment found facilities with RRA-ready systems reduced inspection-related downtime by 65%. That’s why 73% of Fortune 500 pharmaceutical companies implemented RRA-ready documentation by Q1 2025. For example, a biologics manufacturer in Texas used RRAs to avoid shutting down production for a week-long physical inspection, saving $250,000 in lost output. But RRAs have limits. They can’t replace physical inspections for high-risk facilities or when serious compliance issues are suspected. The FDA still needs to see the actual facility during routine surveillance or "for-cause" inspections.
Recent Changes in Inspection Policies
FDA Commissioner Robert Califf announced in May 2025 that the agency will increase unannounced inspections of foreign facilities from 12% to 35% by the end of 2025. This follows the 2024 GAO Report (GAO-24-105123), which found foreign facility compliance rates were lower than domestic ones. McGuireWoods’ 2025 analysis shows domestic inspections remain mostly scheduled (92% frequency), while foreign facilities face stricter rules. For-cause inspections-triggered by complaints or adverse events-made up 18% of 2024 inspections. During these, the FDA gains full access to all records, including internal audit reports. Routine surveillance inspections (75% of pharmaceutical inspections) only allow access to production records and quality control investigations, not internal audits. The 2024 bipartisan Pharmaceutical Supply Chain Transparency Act (S. 2884) proposed public disclosure of certain inspection findings. PhRMA opposes this, arguing it would "undermine the protected space for internal quality audits essential to continuous improvement." But FDA’s 2025 Strategic Plan targets a 25% reduction in inspection cycle times through digital record systems, signaling a shift toward more transparent but efficient oversight.
Practical Steps for Compliance
Companies spend an average of $385,000 annually on inspection readiness, according to TheFDAGroup’s 2025 benchmarking study of 120 facilities. Here’s what works:
- Separate protected vs. required records: Use clear documentation protocols to distinguish between internal QA audits (protected under CPG Sec. 130.300) and quality control investigations (required under 21 CFR 211.192). The Parenteral Drug Association’s 2025 Inspection Readiness Guide says this takes 200-300 hours of quality system documentation.
- Train staff early: New quality personnel need 6-9 months of specialized training. Regulatory Affairs Professionals Society (RAPS) certification increases preparedness by 37% based on 2024 data.
- Use digital tools: Companies with electronic record systems respond to Form 483 40% faster than paper-based ones. FDA’s 2024 Warning Letter Analytics Dashboard shows 22% of warning letters cited "contemporaneous records" violations-meaning real-time documentation was missing.
| Inspection Type | Frequency | Records Access | Key Requirements |
|---|---|---|---|
| Routine Surveillance | 75% of pharmaceutical inspections | Access to production records, validation data, and quality control investigations; not internal QA audits | Scheduled inspections; Form FDA 482 issued; 15-day response for Form 483 |
| For-Cause | 18% of 2024 inspections | Full access to all records including internal audit reports | Triggered by complaints or adverse events; unannounced; higher risk of enforcement |
| Remote Regulatory Assessment (RRA) | 8% of inspections in H1 2025 | Read-only access to digital records; no physical inspection | Conducted via secure portals; no Form 483; used for ongoing monitoring |
Frequently Asked Questions
Can the FDA inspect internal quality audit reports?
Generally, no. Under Compliance Policy Guide Section 130.300, the FDA does not review internal quality assurance audit reports conducted according to a company’s written quality program. This policy encourages candid internal reviews. However, if the audit is part of a quality control investigation or addresses a specific product issue, those records must be made available.
How long do companies have to respond to a Form FDA 483?
Exactly 15 business days. The FDA’s 2023 Guidance for Industry specifies this timeframe. Missing the deadline can lead to warning letters or enforcement actions. Companies that respond quickly with detailed root cause analysis have a much higher success rate in resolving issues.
What’s the difference between routine and for-cause inspections?
Routine inspections are scheduled and account for 75% of pharmaceutical inspections. They focus on general compliance and don’t review internal audit reports. For-cause inspections happen when there’s a complaint or adverse event, making up 18% of inspections. During these, FDA inspectors can access all records, including internal audits, and often occur unannounced.
Are Remote Regulatory Assessments replacing physical inspections?
Not entirely. RRAs are used for ongoing monitoring and low-risk facilities but can’t replace physical inspections for high-risk situations or serious compliance issues. In the first half of 2025, RRAs accounted for only 8% of total inspections. They’re a supplement, not a replacement, for hands-on oversight.
Why is FDA increasing unannounced foreign inspections?
The 2024 GAO Report found foreign facilities had lower compliance rates than domestic ones. FDA Commissioner Robert Califf stated the agency will increase unannounced inspections from 12% to 35% by end-2025 to address this. This shift reflects growing concerns about global supply chain safety and the need for more rigorous oversight of international manufacturing sites.
