FDA 483 - Wells Pharmacy, Inc - September 13, 2016

The FDA Form 483 details observations from an inspection, highlighting significant quality system and manufacturing issues. From February 22, 2016, to July 7, 2016, the firm detected high levels of fungal growth, including Penicillium spp., Cladosporium spp., unidentified basidiomycete, unidentified coelomycete, Bacillus spp., and Aspergillus sydowii, during routine Environmental Monitoring (EM) of active viable air within the IV Clean Room (ISO 5 area). Despite this, sterile drug production continued without immediate investigation. An investigation initiated on July 29, 2016, identified a ceiling tile with fungal growth near a fire sprinkler as the source. Concurrently, three batches of sterile injectable products (HCG 5,000 iu lyophilized injectable lot # 06302016@95, Quad 1 lyophilized injectable lot # 06302016@95, and Quad 2 injectable lot # 07072016@95) failed sterility testing and were destroyed.

Further observations include the firm's failure to conduct smoke studies of the aseptic processing area under dynamic conditions. Specifically, the aseptic processing environment in the (b)(4) Clean Room, which is under negative pressure, lacked smoke studies demonstrating protection of non-hazardous sterile drug products from microbial contamination. The firm continued producing sterile drug products