Refusing FDA Inspection Access

GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves during an inspection, what types of information FDA is allowed to request, and understanding what can go wrong if staff do not allow access to the specific areas of the facility.

This warning letter is an extreme example of what not to do during an inspection. The company, a cosmetic and topical OTC manufacturer, was issued a letter for not allowing FDA to enter certain areas of their facility, but it doesn't stop there. Apparently, the quality manager shoved and shouted at FDA investigators? As my daughter would say, "WTF."

• From warning letter. "Quality Manager entered the laboratory and exhibited hostility by shoving and shouting at our investigators for conducting the inspection without their presence. Additionally, laboratory staff refused to open a drug stability chamber based on his hostile behavior.

FDA inspectors are real people, and common courtesy goes a long way, such as offering them water (do not offer anything else as it is considered inappropriate), suggesting a good restaurant for lunch, and just being nice. It goes without saying that shouting and shoving anyone, especially FDA, is bad, and it would set up the rest of the inspection to go much worse than it could have. Employee training and mock FDA inspections are a critical part of a smooth "real" GMP inspection.

It is standard practice for FDA to request a list of complaints to ensure they are being investigated properly. A customer complaint related to mold and its associated investigations was not disclosed in the list of complaints provided to the FDA. The section of the warning letter is sad and potentially speaks to an unfriendly and potentially fishy work environment.

• From warning letter. "While interviewing an employee regarding the undisclosed positive mold results for your …. your Quality Manager entered the room and began berating the employee, who then left the room, impeding FDA's review of your contamination investigation required under CGMP."

There are several other GMP citations listed in the warning letter.

• Failure to Test Finished Products (21 CFR 211.165(a)).

• Failure to Test Components for Identity and Purity (21 CFR 211.84(d)). Testing glycerin for diethylene glycol (DEG) or ethylene glycol (EG) is mentioned here. FDA is very serious about this and has been mentioned in 40+ warning letters this year.

• Inadequate Facility and Storage Conditions (21 CFR 211.42(b)).

• Inadequate Quality Unit Oversight (21 CFR 211.22).

• Lack of Process Validation and Cleaning Validation (21 CFR 211.100(a) and 211.67(b)).

This warning letter reads like a bad movie and makes the company look unprepared and non-compliant. Read the full letter here. 

DATE ORIGINALLY POSTED: 12/25/24

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.