FVS Holdings, Inc. (dba Green Valley Drugs) — FDA 483 Findings

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

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

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient Specifically, on 3/11/2013, raw materials for multiple lots of sterile drug products were observed in white plastic unlabeled weigh boats sitting on top of formula sheets on a counter in the ISO Class 8 Anteroom.

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

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

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

Procedures designed to assure that correct labels are used for drug products are not followed.

There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.

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

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

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.