Wellcare Rx Investments LLC dba Denson’s Specialty Pharmacy — FDA 483 Findings

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

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

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess .

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

Routine calibration, inspection, and checking of electronic equipment is not performed according to a written program designed to assure proper performance .

Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.

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

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

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

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

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

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

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

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

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

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