BBS Pharmacy, Inc. dba B&B Pharmacy – FDA 483, Aug 18, 2015

An FDA inspection of Pacific Healthcare, Inc dba B&B Pharmacy, a producer of sterile drug products, was conducted from August 3-18, 2015. The inspection revealed significant deviations from manufacturing quality standards, detailed in a Form 483. Main violations included inadequate procedures to prevent microbiological contamination, such as improper aseptic technique by technicians and deficient media fill policies that did not simulate actual production. The firm also failed to validate depyrogenation for glassware and sterilization processes for stoppers and seals, which were not tested for endotoxin. Environmental monitoring programs were severely lacking, with no written procedures for viable or non-viable monitoring, and no smoke studies performed. Product testing and release protocols were insufficient, evidenced by the use of raw materials with particulates in sterile drug production and a lack of proper visual inspection or investigation into product precipitates. Cleaning and disinfection practices were substandard, involving non-sterile materials and improper personnel gowning. Facility deficiencies included non-smooth, non-cleanable surfaces in aseptic areas. Most critically, the firm lacked a written program for stability testing, resulting in inadequate sterility and endotoxin testing for numerous sterile preparations and unsupported Beyond Use Dates. The company is required to implement comprehensive corrective actions to address these serious deficiencies and ensure compliance with regulatory standards.