Czech API manufacturer hit with FDA warning letter over contamination, data issues
Following an inspection at the company’s site in the Czech Republic last June, FDA investigators found that VUAB received a customer complaint related to a Clostridium sphenoides contamination of a specific lot of an unspecified API (active pharmaceutical ingredient). And not only did VUAB fail to detect the contamination, but the customer conducted an on-site audit of VUAB had to show the company how to modify its test methods to detect Clostridium sphenoides growth.
In addition, the FDA says the company’s response to retroactively test particular batches “is not scientifically sound” as it “does not evaluate all batches that could be contaminated with objectionable organisms.”
VUAB also received another customer complaint concerning Bacillus spp. contamination of another API lot, though during its investigation of the contamination, the company “did not extend the investigation to any other batches potentially affected. In addition, deficient sampling procedures compromised your firm’s ability to detect the contamination your customer found,” the FDA says.
In response to these contamination issues, the agency is calling on VUAB to provide it with a number of pieces of information, including an accelerated timeline for completing retroactive testing of all potentially affected batches, a detailed update on a root cause of the contamination, an improved deviation and CAPA (corrective action and preventive action) management procedure, and a review of all microbial test methods to ensure they are suitable for their intended use.
Data Integrity
In addition to the microbiological contaminations, the FDA cited VUAB for its failure to retain complete raw data from testing performed to assure the quality of one unnamed API.
“Our inspection revealed discrepancies between the printed chromatograms and the operational qualification protocol for the High Performance Liquid Chromatography (HPLC) system, which is intended to demonstrate correct operation of the HPLC. These discrepancies included injection sequences and values to calculate relative standard deviation (RSD),” the FDA said.
“This lack of control over the integrity of your data raises questions about your analytical data’s authenticity and reliability, and about the quality of your APIs,” the agency added. It also asked the company to provide a comprehensive corrective action plan for computer system controls over all laboratory and manufacturing instrumentation and equipment.
