Understanding FDA Inspection Records: What Manufacturers Need to Know

Understanding FDA inspection records is critical for manufacturers navigating today's regulatory landscape. The U.S. Food and Drug Administration (FDA) has strict rules about what records they can access during facility inspections, and these rules directly impact your compliance status. Did you know that 90.2% of pharmaceutical manufacturing facilities met FDA compliance standards in 2018-2022? But what happens when they don’t? Let’s break down exactly what FDA inspection records entail and how to prepare.

What FDA Can Access During Inspections

The FDA’s authority to inspect manufacturing facilities comes from Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, not all records are equally accessible. Under Compliance Policy Guide (CPG) Sec. 130.300, the FDA generally does not review internal quality assurance audit reports during routine inspections. This policy exists to encourage companies to conduct honest internal reviews without fear of regulatory penalties. On the other hand, the agency has full access to production records, validation protocols, deviation investigations, and CAPA (Corrective and Preventive Action) documentation. For pharmaceutical manufacturers, 21 CFR 211.180 requires retention of these records for at least one year after a drug’s expiration date. Medical device makers must follow 21 CFR 820.180, which mandates keeping records for the device’s lifespan plus two years.

Current Good Manufacturing Practices (CGMP) are a set of regulations ensuring products are consistently produced and controlled according to quality standards. These rules form the backbone of FDA inspections. During routine checks, inspectors focus on CGMP compliance, reviewing batch records, equipment logs, and quality control testing data. Companies that fail to maintain these records face warning letters, recalls, or even shutdowns.

The Inspection Process: From Notice to Findings

When FDA inspectors arrive, they start with Form FDA 482 (Notice of Inspection). This document explains the scope of the inspection and legal authority. After reviewing records, inspectors issue Form FDA 483 (Notice of Inspectional Observations) if they find issues. This form lists specific violations, such as inadequate sanitation or missing documentation. Companies must respond to Form 483 observations within exactly 15 business days, as required by FDA’s 2023 Guidance for Industry. Failure to respond on time can escalate to legal action or product recalls.

According to a 2024 ECA Academy survey of 215 quality executives, 41% reported inconsistent interpretations of CPG Sec. 130.300 between different FDA district offices. This inconsistency creates confusion for manufacturers trying to determine what records to prepare. For example, one district office might request internal audit reports during a routine inspection, while another strictly follows the policy. This unpredictability forces companies to maintain extra documentation just in case.

Routine vs. For-Cause Inspections: Key Differences

Not all FDA inspections are the same. In 2024, routine surveillance inspections accounted for 75% of pharmaceutical inspections, while for-cause inspections made up 18%. Routine inspections are scheduled and focus on general compliance with CGMP requirements. During these checks, the FDA does not review internal quality assurance audit reports per CPG Sec. 130.300. For-cause inspections, however, happen when the agency has specific concerns, such as customer complaints or product failures. During these unannounced checks, the FDA gains full access to all records, including internal audit reports.

Foreign Facilities and Unannounced Inspections

Foreign manufacturing facilities face stricter scrutiny than domestic ones. In 2023, only 12% of foreign facility inspections were unannounced. But in May 2025, FDA Commissioner Robert Califf announced a major shift: unannounced inspections for foreign facilities will rise to 35% by the end of 2025. This change follows concerns raised in the 2024 GAO Report (GAO-24-105123) about inconsistent compliance at overseas plants. The move aims to address supply chain risks and ensure global manufacturing standards match U.S. requirements.

Domestic facilities, meanwhile, maintain scheduled inspection protocols at 92% frequency according to McGuireWoods’ 2025 analysis. This disparity creates challenges for multinational companies that must adapt to different inspection approaches in different regions. For example, a U.S.-based company with factories in India and Germany must prepare for unannounced checks in Germany but scheduled inspections in the U.S.

Remote Regulatory Assessments (RRAs)

Remote Regulatory Assessments (RRAs) represent a significant evolution in FDA inspection methods. Finalized in July 2025, RRAs allow the agency to conduct virtual evaluations using digital records, read-only database access, or remote interactive sessions. Unlike physical inspections, RRAs don’t generate Form 483 observations. In the first half of 2025, RRAs accounted for only 8% of total inspections, but they’re growing quickly. FDA’s 2025 RRA Impact Assessment shows facilities using RRAs reduced inspection-related production downtime by 65%. This efficiency has driven 73% of Fortune 500 pharmaceutical companies to implement RRA-ready documentation systems by Q1 2025.

Remote Regulatory Assessment (RRA) is a digital evaluation method that substitutes for physical inspections in certain circumstances. While RRAs save time and costs, they require robust electronic record systems. Companies without digital infrastructure face challenges adapting, especially smaller manufacturers who lack the resources to overhaul their documentation processes.

Practical Steps for Compliance

Preparing for FDA inspections isn’t optional-it’s essential. According to a 2025 TheFDAGroup benchmarking study of 120 facilities, 78% of pharmaceutical manufacturers maintain dedicated inspection readiness teams. These teams spend an average of $385,000 annually on preparation, including staff training, record organization, and mock inspections. The Parenteral Drug Association’s 2025 Inspection Readiness Guide recommends allocating 200-300 hours to document quality system processes clearly. This includes distinguishing between protected audit reports (under CPG Sec. 130.300) and mandatory quality control records (under 21 CFR 211.192).

New quality personnel typically need 6-9 months of specialized training to understand FDA requirements. Certification through the Regulatory Affairs Professionals Society (RAPS) increases preparedness by 37% based on 2024 industry data. When responding to Form 483 observations, companies following the FDA’s recommended root cause analysis methodology achieve closure rates of 89% within six months, compared to just 62% for those using simplified approaches. This difference can mean the difference between a quick resolution and a prolonged regulatory battle.

Current Trends and Future Changes

The regulatory landscape is evolving rapidly. FDA’s 2025-2027 Strategic Plan targets a 25% reduction in inspection cycle times through enhanced digital record systems. Meanwhile, industry analysts project a 40% increase in enforcement actions against facilities delaying or denying inspection access. This follows a 17% year-over-year rise in warning letters related to Section 301(f) of the FD&C Act, which prohibits refusing inspections. The 2024 bipartisan Pharmaceutical Supply Chain Transparency Act (S. 2884) proposes mandatory public disclosure of certain inspection findings, though PhRMA opposes it, arguing it would undermine internal quality audits.

The global pharmaceutical manufacturing compliance market, valued at $12.7 billion in 2024 with 8.3% annual growth, is increasingly focused on inspection readiness solutions. As FDA expands unannounced inspections and RRAs, manufacturers must adapt quickly. Those who invest in digital record systems and trained staff will navigate these changes smoothly, while others risk costly delays and regulatory penalties.