FDA 483 - FVS Holdings, Inc. dba. Green Valley Drugs - March 15, 2013

The FDA Form 483 details significant deficiencies at a facility producing sterile drug products. Key issues include personnel not wearing appropriate sterile attire (gloves, lab coats, masks, hair nets, shoe covers, eye protection) during aseptic operations, with exposed skin observed. Sterilized vials were stored uncovered, approximately one foot from the floor, in an ISO Class 7 Cleanroom, risking contamination.

The facility failed to test components for purity, strength, and quality, including bioburden, relying solely on supplier analyses without validation. Numerous aseptic processing violations were observed, such as technicians contacting sterile vials and stoppers with non-sterile gloves, fiber residue in the laminar air flow hood (LAFH), technicians' upper bodies entering the LAFH with exposed skin, sporadic movements, multiple technicians working concurrently in a single LAFH, and inadequate sanitization of equipment.

Sterilization processes lacked validation for autoclaves and dry heat ovens, including maximum load patterns and impact on drug product identity/stability. Media fill tests did not simulate challenging production conditions. The facility failed to investigate multiple out-of-specification (OOS) potency results for sterile drug products, a repeat observation. Finished sterile drug products did not consistently undergo sterility and/or endotoxin testing, with many lots released without such testing. Potency testing was not performed on all lots prior to release, and no written stability testing program existed, leading to products with unconfirmed expiry dates and one stability failure without investigation.

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