FDA Warns Czech API Maker Over Contamination, Data Integrity Issues

Active pharmaceutical ingredient maker VUAB Pharma was hit with an FDA warning letter over complaint handling, contamination and data integrity issues.

According to the May 27 letter, the Czech company failed to investigate and resolve two customer complaints related to microbial contamination of product. In January 2014, VUAB received a complaint that an API contained Clostridium sphenoides, but the company wasn’t able to detect the contamination itself until an audit conducted by the customer forced the firm to modify its testing method.

Afterward, the company still failed to identify the source of the contamination or to implement meaningful corrective actions to prevent future microbial contamination, the FDA says.

An April 2014 complaint about APIs contaminated with Bacillus spp. was confirmed by VUAB, but the testing methods that were used provided no justification that the sample was representative of the entire batch, the agency adds. The company also didn’t extend the investigation to see if other batches were affected.

VUAB’s response included no improvements to its CAPA procedure and didn’t identify the root cause of the contaminations, the FDA says.

During the June 9 to 13, 2014, investigation of VUAB’s Roztoky, Czech Republic, facility, investigators found that the firm lacked controls to prevent unauthorized access or changes to data.

VUAB also didn’t maintain a back-up of high-performance liquid chromatography chromatograms, which form the basis of its product release decisions, the warning letter says. When investigators requested the original raw data, the quality unit said back-up discs were unreadable and had been since 2013. Also, the HPLC system lacked access controls to prevent alteration or deletion of data.

The FDA asked VUAB to provide a corrective action plan for computer system controls, as well as an accelerated timeline for completing retroactive testing of all potentially contaminated API batches. The agency also wants a detailed update on the root cause of the contaminations and the risk controls the company has implemented.

Foreign facilities, including API manufacturers, have been under increased scrutiny by the FDA, resulting in recent warning letters for firms in Thailand and China.

VUAB did not respond to a request for comment by press time. View the warning letter at www.fdanews.com/06-05-15-VUAB.pdf. — Kellen Owings