Cantrell Drug Company — FDA 483 Findings

The building lacks adequate space for the orderly placement of equipment and materials to prevent mix- ups between different components, drug product containers, labeling, in-process materials and drug products and to prevent contamination.

Specifically, the following deficiencies were observed during the current inspection: 1.

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

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

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

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

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

The labels of your outsourcing facility's drug products are deficient.

There is no written testing program designed to assess the stability characteristics of drug products.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.

Deviations from written production and process control procedures are not recorded and justified.