FDA 483 - Wells Pharmacy Network LLC - June 19, 2014

The FDA Form 483 details multiple repeat observations concerning the facility's sterile drug product manufacturing. Procedures to prevent microbiological contamination are deficient, as media fills for operator qualification lack growth promotion tests and environmental monitoring during sampling and fills. Aseptic processing areas are inadequate regarding HEPA-filtered air supply, with cleanroom and laminar air flow hood qualifications not including dynamic conditions, smoke studies, or quality review.

Environmental monitoring is insufficient, with surface and air monitoring of ISO 5 workstations conducted on a (b)(4) basis despite (b)(4) product preparation, and personnel fingertip sampling also on a (b)(4) basis. Growth promotion testing for environmental monitoring media is not performed. The efficacy of cleaning and disinfecting agents for ISO classified areas has not been assessed.

Sterility testing for drug products is problematic; method validation for the (b)(4) instrument used for all sterile products, including Sermorelin Acetate, is not established. Documentation defining results, evaluation processes, or actual evaluations of events is absent. Lyophilization cycle procedures for Sermorelin Acetate lack written procedures or scientific data, relying on visual inspection for dryness.

The firm lacks a written stability program and reliable scientific data to support the 180-day beyond-use date for Sermorelin Acetate, relying on literature. Conflicting beyond-use dates were noted on formula worksheets and labels. Stability testing for reconstituted products is also absent.

Personnel clothing is inappropriate