Industry still facing Problems with Root Cause Investigations

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations. A look at the FDA's so-called 483s is also interesting here. The observations made by the inspector during an inspection are listed on the FDA Form 483. What many people do not know is that FDA summarises results from the 483s in tables and publishes them in their overview entitled "Inspection Observations".

According to the current file, 349 corresponding forms were issued in the area of "Drugs" in fiscal year 2020. With 79 observations, violations of section 21 CFR 211.192 ("Investigations of discrepancies, failures") are in second place. Primarily, this concerns problems and failures in the review of unexplained deviations and specifications that have not been met. The "Written record of investigation" required in the same paragraph was objected to 28 times. Here, written records of investigations do not always include conclusions and follow-up, or are not even present.