Stewart Compounding Pharmacy — FDA 483 Findings

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

Clothing of personnel engaged in tbe processing of drug products is not appropriate for the duties they perform.

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

The written stability testing program is not followed.

Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure tha t they are suitable for their intended use.

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

Aseptic processing areas are deficient in that floors are not smooth and/or har d surfaces that are easily cleanable.

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

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

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