The FDA cited an Aurobindo facility for lax documentation and investigations of product failures.
A September inspection of the plant in Telangana found that the drugmaker did not thoroughly review unexplained discrepancies or the failure of a batch or its components to meet specifications regardless of whether it had already been distributed.
For example, the agency flagged one investigation for several batches of tablets that was meant to investigate stability testing failures. The agency officials could not determine if the studies were actually conducted. They observed similar problems with investigations of product complaints related to broken tablets, as well as discolored tablets.
The facility lacked written procedures for production and process controls to ensure that the drug products had the claimed qualities. It also lacked control procedures for processes that could cause variability in drug products, the agency said.