Incomplete Quality Investigations Land Indian Drugmaker 483

Agila Specialties failed to conduct complete investigations into customer complaints, forcing the FDA to give the Indian manufacturer with a Form 483.

During an August inspection of Agila’s Bangalore facility, investigators discovered that investigations into discolored vials with high impurities didn’t provide enough data to support a root cause. The investigation also didn’t look into whether other drug products had similar problems.

In addition, prior to October 2013 there wasn’t a requirement in the pharmacovigilance group to share complaint information with the quality unit, reads the form with 12 observations. “As a result, reports received by the pharmacovigilance may not have been investigated with respect to their impact on the quality of product,” the FDA said.

The form gave an example of a report that a product was discolored but this wasn’t investigated by the quality unit.

The FDA also found problems with Agila’s facility and equipment, discovering multiple leaks in the facility’s water system. The stability chambers are also too small to accommodate all products, the agency added.

Building and implementing an effective CAPA compliance program will help you investigate the cause of poor quality results. So purchase Managing Effective CAPA Systems today!