FDA 483 - The Compounding Shop, Inc. - March 22, 2013

This FDA Form 483 document details observations made during an inspection, indicating significant deficiencies in the facility's manufacturing and quality control processes for drug products, particularly those purporting to be sterile.

Key violations include the absence of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. The aseptic processing areas were found deficient in several aspects: the system for monitoring environmental conditions, the air supply (lacking HEPA filtration under positive pressure), and the cleaning and disinfection system. Equipment and utensils were not maintained at appropriate intervals to prevent contamination.

Furthermore, the facility failed to adequately test each batch of drug product required to be free of objectionable microorganisms. Sterilization processes lacked adequate validation. There were no written standards, specifications, testing methods, cleaning methods, or sterilization methods to remove pyrogenic properties. Personnel clothing was deemed inappropriate for their duties.

Finally, the testing and release of drug products for distribution did not include appropriate laboratory determination of conformance to final specifications, identity, and strength of active ingredients prior to release. A written testing program to assess drug product stability characteristics was also absent. These observations highlight critical deficiencies across quality systems, manufacturing controls, and laboratory operations, indicating potential risks to drug product safety, identity, strength, quality, and purity.