FDA 483 - Central Admixture Pharmacy Services, Inc. - August 22, 2018

This FDA Form 483 document details observations from an inspection related to the aseptic processing of drug products. The facility exhibits deficiencies in maintaining separate or defined areas to prevent contamination or mix-ups during aseptic operations. Procedures to prevent microbiological contamination of sterile drug products are not established and followed. The system for monitoring environmental conditions in aseptic processing areas is also deficient.

A critical finding is the failure to thoroughly review unexplained discrepancies and batch failures to meet specifications, even for distributed batches. The responsibilities and procedures of the quality control unit are not documented in writing and fully followed. Furthermore, buildings used for manufacturing, processing, packing, or holding drug products are not maintained in a clean and sanitary condition, and are not free of infestation by rodents, birds, insects, and other vermin.

Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to sterility requirements. Finally, written procedures for the preparation of master production and control records are not described. These observations indicate significant issues with quality control, environmental monitoring, contamination prevention, and documentation within the facility's sterile drug product manufacturing operations.