New Warning Letter calls for Risk Assessments

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

In a recent Warning Letter issued to a pharmaceutical company based in North Carolina, the U.S. Food and Drug Administration FDA explicitly asks the company to perform risk assessments.

The company produced both human drugs and several pesticides in the same building and with the same equipment. This is certainly a 'no go' for the FDA. The company now has to provide a risk assessment for all drugs which have been produced on the equipment also used for pesticide production and evaluate the "risk of potential contamination due to the shared equipment", and to address "the product quality and patient safety risks for any product still in distribution within expiry, including potential recalls or market withdrawals".

Even worse, the company had no adequate cleaning validation in place. Also here the FDA now wants a "risk evaluation that addresses the potential for each of your human drugs to be cross-contaminated with any other products".

Please also see the FDA Warning Letter to Ei LLC for more detailed information.