Insufficient Root Cause Analysis results in FDA Warning Letter

Intercos Europe S.p.A. in Italy recently received an FDA Warning Letter due to failures in testing incoming raw materials, investigating deviations, and missing data.

Issues Identified:

The company experienced multiple microbial excursions but quickly attributed the results to sampling errors without proper investigation or root cause analysis. The FDA emphasized that without investigating microbial failures, the company cannot ensure compliance with microbiological and chemical standards. Additionally, changes were made to batch records without adequate investigation, as the changes were attributed to a supervisor’s action.

FDA Requirements:

1. Complete Investigations: The company must investigate all test results exceeding the microbial action limit from the past three years, detailing the root causes of contamination.

2. Risk Assessment: A detailed risk assessment is needed for all drug product lots within expiry in the U.S. to address potential hazards.

3. Independent Assessment: An independent evaluation of the system for investigating deviations, discrepancies, complaints, OOS results, and failures is required, along with a detailed remediation plan.