Medaus, Inc. — FDA 483 Findings

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

Drug products are not stored under appropriate conditions oftemperature and light so that their identity, strength, quality, and purity are not a~ected .

Aseptic processing areas are deficient reg arding the system for cleaning and disinfecting the room and equipment to produ ce aseptic conditions.

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

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

Each batch of drug product purporting to be sterile is not laboratory tested to determine to such requirements.

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

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

Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product Specifically, the firm does not have any hold time data to support the completion of each production phase for any of yo ur injectable drug product...

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

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

Laboratory controls do not include determination of conformance to appropriate written specifictions for the acceptance o f each lot within each shipment of compoents, drug product containers, closures, and drug products used in the manufacture, pr ocessing, packing, or holding of drug products.