FDA Inspector Michael A. Charles focuses on five major areas during pharmaceutical inspections: cleaning validation, process control, lab testing, microbiological control, and training. His observations reveal recurring compliance gaps that could lead to Form 483s or warning letters.

Who is Michael A. Charles?

Michael A. Charles is a senior FDA investigator with years of experience in pharmaceutical inspections. His inspection reports are often referenced for their clarity, consistency, and emphasis on core GMP requirements. Facilities inspected by him frequently receive citations tied to documentation gaps, insufficient controls, and overlooked contamination risks. His reviews are known to be thorough and detail-oriented.

Why Do His Inspections Matter?

In 2024 alone, the FDA issued over 700 Form 483s, with nearly 42% involving cleaning validation, documentation gaps, or failure to control critical parameters. Michael A. Charles consistently identifies such gaps, making his inspections a reflection of broader FDA expectations. He inspects both U.S. and overseas facilities, and his findings have shaped how manufacturers approach cGMP readiness.

1. Cleaning Validation

One of the most cited issues in Michael’s inspections is poor cleaning validation practices. Many firms either lack documented cleaning procedures or have documents that are too vague to ensure repeatability. For example, in one inspection, cleaning SOPs failed to define residue limits, rationale for swab locations, or acceptable cleaning agents.

The absence of cleaning validation puts drug products at risk of cross-contamination. In 2024 alone, FDA issued over 60 warning letters citing failures in cleaning validation. Many of these cases involved shared manufacturing lines without clear evidence that residues were adequately removed between product runs.

2. Control of Critical Process Parameters

Michael often notes missing or poorly defined control procedures for manufacturing operations. This includes operating ranges for parameters like temperature, pressure, flow rates, and mixing speed. In several inspections, batch records lacked real-time monitoring data or had handwritten notes without timestamps or approvals.

This kind of data inconsistency can directly affect drug quality. Without process controls, variability becomes a major issue. For example, in a 2023 inspection report, one facility failed to monitor fill volume during aseptic processing, leading to underfilled vials and product recalls.

3. Laboratory Controls and Method Validation

Another key focus area is laboratory testing. Many firms rely entirely on vendor Certificates of Analysis (CoAs) without conducting their own identity, strength, and purity tests. Michael has frequently cited facilities under 21 CFR 211.84 for accepting raw materials without verification.

He also emphasizes validated methods for quality control testing. Some firms failed to validate their HPLC or microbiology testing methods. In one warning letter, the absence of method validation led to the release of a sub-potent product, which was later recalled.

According to FDA data, over 40% of lab-related 483 observations in the last year involved non-validated or poorly executed test methods.

4. Microbiological Controls in Aseptic Areas

Michael’s inspections also spotlight poor aseptic practices. Common issues include unwashed caps entering Grade A areas, lack of environmental monitoring during filling operations, and personnel touching sterile components without proper gowning.

In one inspection, the environmental monitoring records showed recurring microbial counts in critical areas, but no investigation or corrective action was taken. This kind of oversight can lead to sterility failures, and in injectable products, that’s a direct patient safety threat.

FDA’s 2023 sterility assurance review revealed that nearly 1 in 5 sterile drug facilities had major deficiencies in microbial control procedures.

5. Corrective and Preventive Action (CAPA) and OOS Handling

Out-of-specification (OOS) results require structured investigation, but Michael found that companies often closed OOS cases without identifying the true root cause. In several inspections, CAPA procedures were either missing, generic, or reactive instead of preventive.

For example, one company repeatedly received OOS results for microbial limits but continued using the same water system without modification. This type of repeat violation signals poor quality oversight.

Effective CAPA is crucial. FDA’s database shows that about 30% of warning letters issued in 2024 cited inadequate CAPA processes as a core issue.

6. Personnel Training and Recordkeeping

Michael also inspects training records closely. He often finds incomplete or outdated training logs, especially for operators involved in critical production steps. Lack of job-specific training can lead to errors in documentation, cleaning, or aseptic handling.

In one case, operators were unfamiliar with basic gowning procedures despite working in sterile environments. This raises questions about management oversight and long-term compliance.

A Proactive Guide for QA Teams

Establish detailed cleaning validation protocols with scientifically justified acceptance criteria
Implement a real-time monitoring system for all critical manufacturing parameters
Validate all test methods used in lab analysis and verify vendor CoAs through sampling
Strengthen microbiological monitoring in aseptic zones with clear response procedures for excursions
Build a robust CAPA process with detailed root cause analysis and documented follow-ups
Ensure all staff are trained regularly on cGMP and their specific job functions, with verifiable records

Inspections by Michael A. Charles reveal a pattern of overlooked fundamentals—cleaning, monitoring, testing, and training. Companies that fail in these areas often end up with repeat citations and costly remediations. For QA leaders, understanding these trends is not just about passing inspections; it’s about ensuring patient safety, product quality, and regulatory trust.

Most Frequently Asked Questions

Q. What is the role of an FDA inspector like Michael A. Charles?
A. FDA inspectors evaluate drug manufacturing facilities for compliance with cGMP to ensure the safety and effectiveness of pharmaceutical products.

Q. How often does the FDA inspect pharmaceutical facilities?
A. Typically every 2-3 years, or more frequently if there are complaints, recalls, or risks identified.

Q. What are the most cited 483 observations?
A. Common issues include inadequate cleaning validation, poor documentation practices, lack of method validation, and incomplete investigations of deviations.

Q. How can a company prepare for an FDA inspection?
A. Companies can prepare by maintaining updated Standard Operating Procedures (SOPs), regularly training employees on cGMP and job-specific responsibilities, conducting routine internal audits, validating all processes and test methods, and responding promptly to quality issues with a strong Corrective and Preventive Action (CAPA) system.

For a more data-driven and inspection-ready approach, platforms like Atlas Compliance can help QA teams stay ahead by offering real-time insights from past FDA inspections, access to Form 483 and EIR data, and an AI Copilot that guides your team in preparing smarter, faster, and with greater accuracy.

What Does FDA Inspector Michael A. Charles Focus On During Site Inspections?