US FDA issues another warning letter over failures at Apotex' Indian plant

The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics drugmaker Apotex, regarding its Bangalore-based Apotex Research Private citing serious manufacturing violations.

In a letter to the company this month, the FDA said that, during its June and July inspections of the Bangalore facility, its investigators identified significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.

The violations include failure to ensure that laboratory records included all necessary testing-compliance data; failure to ensure that only authorised personnel have access to the master control functions of the computer system; and failure to establish appropriate procedures to prevent bacteria from developing.