Cantrell Drug Company — FDA 483 Findings

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

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

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

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

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

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

Test procedures relative to appropriate laborat01y testing for sterility and pyrogens are not written and followed.

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

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

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

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

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