Biocon Ltd. — FDA 483 Findings

Employees engaged in the manufacture and processing ofa drug product lack the training and experience required to perform their assigned functions.

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

The quality control unit lacks the responsibility-and authority to approve and reject all components and drug ~ wis a5 RE]TAT

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe sterilization process.

Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written and followed.

Aseptic processing area are deficient regarding the system for monitoring environmental conditions.

Investigations of an unexplained discrepancy did not extend to other batches ofthe same drug product and other drug products that may have been associated with the specific failure or discrepancy.