Qualgen LLC — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of i ts components to meet any of its specifications whether or not the batch has been already distributed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.

Each batch of drug product required to be free of objectionable microorganisms is not tested through a ppropriate laboratory testing.

Written procedures are not established and followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.