The Compounding Shop — FDA 483 Findings

Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to : assure proper performance.

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

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

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.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.

There are no written standards or specifications, methods of testing, methods of cleaning, and methods of sterilization to remove pyrogenic properties.

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

Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.

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