US Specialty Formulations LLC. — FDA 483 Findings

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

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

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

Protective apparel is not wom as necessary to protect drug products from contamination.

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

Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable location to facilitate cleaning, maintenance, and proper operations.

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

Testing and release ofdrug product for distribution do not include appropriate laboratory determination of satisfactory conformance to tbe final specifications prior to release.

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