The FDA flagged API manufacturer Emcure Pharmaceuticals, citing inadequate validation, testing and reporting.
FDA officials inspected Emcure’s Pune, India facility in late February and early March of 2016 and, in a Form 483, said the facility lacked adequate validation of its cleaning procedures. For example, the cleaning methods for production equipment were not properly validated.
In another observation, the agency noted impurities in API batches were not properly described, and they were not compared with historical data or validation batches.
The agency also faulted Emcure for its testing procedures, noting the company failed to conduct at least one test for each batch of incoming raw material to certify its identity prior to using it in the API manufacturing process.