Regulatory Focus™ > News Articles > API Manufacturer Warned by FDA Over Contamination, Data Integrity Issues

API Manufacturer Warned by FDA Over Contamination, Data Integrity Issues

Posted 02 June 2015 | By Alexander Gaffney, RAC 

API Manufacturer Warned by FDA Over Contamination, Data Integrity Issues

A Czech manufacturer of active pharmaceutical ingredients (APIs) has been warned by the US Food and Drug Administration (FDA) for allegedly releasing products contaminated with bacteria.

The company, VUAB Pharma of Roztoky, Czech Republic, was issued a Warning Letter by FDA on 27 May 2015 following a June 2014 inspection of the facility by FDA investigators that found "significant deviations from current good manufacturing practice (CGMP)."

In one notable allegation, FDA said it found a customer complaint indicating that a product was contaminated with Clostridium spehnoides. The problem, FDA noted, is that subsequent testing by VUAB meant to confirm the presence of the bacteria was insufficient to confirm the presence of the bacteria in the returned samples.

"Your test method was inadequate to detect Clostridium sphenoides growth," FDA wrote in its letter to VUAB. "Once you modified the test method per your customer’s recommendation, your firm confirmed Clostridium sphenoides contamination in your retain sample."

However, the company then "failed to identify the source of the contamination or to implement meaningful corrective actions to prevent future microbial contamination," FDA said.

Though the drug in question wasn't shipped to the US, regulators said they were still concerned since the facilities manufactured APIs "using common equipment … regardless of the destination of a given batch."

In another case highlighted by regulators, a customer complaint indicated an API lot was contaminated with Bacillus spp., which was later confirmed as true by VUAB testing. FDA said it found no evidence the company had investigated other batches "potentially affected" by the same contamination. FDA said VUAB also used "deficient sampling procedures" which had limited the effectiveness of its investigation, and again failed to identify the root cause of the deficiency.

Data Integrity Issues

The manufacturer was also cited for failing to "prevent unauthorized access or changes" to its data. As part of the manufacturing process, all testing, process and other data is supposed to be recorded and captured in computerized systems. This is meant to ensure that accountability for testing and results exist, and cannot be retroactively changed.

The problem, FDA said, was that inspectors found VUAB did not have "access controls to prevent alteration or deletion of data," and also lacked "an audit trail recording any changes to the data." The company also did not have a functioning backup system allowing regulators to look at the original raw data.

"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," FDA wrote.

The company's products are currently subject to an import alert preventing its products from being imported into the US.

 

FDA Warning Letter


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe