Right Value Drug Stores, Inc. — FDA 483 Findings

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.

Batch production and control records do not include complete information relating to the production and control ofeach batch.

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 cleaning and disinfecting the room and equipment to produce aseptic conditions.

Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.

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

The flow ofcomponents though the building is not designed to prevent contamination.

Each lot ofa component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view ofits intended use is not subjected to microbiological tests before use.

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

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

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

Batch production and control records do not include the specific identification ofeach batch ofcomponent used for each batch ofdrug product produced.