California Pharmacy & Compounding Center — FDA 483 Findings

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds, insects, and other vermin.

Batch production and control records do not include complete information relating to the production and control of each batch.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

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

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.