FDA 483 - Wells Pharmacy Network LLC - July 26, 2013

The FDA Form 483 inspection revealed significant deficiencies in the manufacturing of sterile drug products, including both human and veterinary injectables. The facility failed to adequately validate sterilization processes, particularly for sterilizing filters, with observed integrity test failures being improperly accepted. Four different types of filters were used for sterile injectable products despite manufacturer statements that they were not certified for parenterals and lacked suitable integrity test methods.

The firm also lacked validation for various filters used to sterilize products from non-sterile components and failed to establish pre-sterilization bioburden limits. Incoming components like Procaine HCL lacked specifications for bacteria, yeast, or mold, and Calcium Gluconate USP anhydrous powder's vendor specifications for bioburden were not verified as adequate.

Sterilization cycles for autoclaves were deficient, with inadequate cycle parameters and empty load verification. Dry heat sterilization validation was also insufficient, with incorrect incubation temperatures for biological indicators and uninvestigated incubator failures. The purified water system used for washing vials and stoppers lacked scientific data to confirm monitoring, sampling, and maintenance to prevent additional bioburden.

Procedures for preventing microbiological contamination were not established or followed. Media fills for operator qualification were inadequate, lacking worst-case conditions, growth promotion tests, and environmental/fingertip sampling. No microbiological data supported the 30-day expiration for in-house sterilized containers. Personnel gowns for sterile processing were not sterile.

The firm failed to thoroughly investigate out-of-specification (OOS