FDA 483 - Wells Pharmacy Network LLC - March 07, 2014

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, specifically Avastin finished product syringes.

Key violations include inadequate procedures for preventing microbiological contamination during sterile compounding. Media fills for operator qualification lacked worst-case conditions, growth promotion tests were not conducted on media, and environmental/fingertip sampling was absent during media fills. These are repeat observations.

Aseptic processing areas were deficient in air supply and environmental monitoring. The ISO 7 cleanroom and ISO 5 laminar air flow hoods (LAFW) were not qualified under dynamic conditions, and smoke studies were not reviewed for adequacy or conducted dynamically. Environmental monitoring was not performed for extended periods (07/27-09/15/13 and 12/18/13-02/04/2014) during which Avastin lots were produced. Daily surface, air, and personnel monitoring in the ISO 5 LAFW was not conducted, and growth promotion testing for environmental monitoring media was lacking. These are also repeat observations.

The facility failed to assess the suitability and efficacy of disinfecting agents, a repeat observation. Finished product testing was inadequate, with no microbiological method suitability testing for Avastin syringes and no endotoxin testing prior to release, another repeat observation.

A written stability program was absent, and the 90-day beyond-use date for Avastin syringes lacked scientific data, relying solely on literature