Pharmathen International S.A. — FDA 483 Findings

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

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

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

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

Established sampling plans and test procedures are not followed and documented at the time of performance.

Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

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