FDA EIR - Buderer Drug Company Inc - January 04, 2016

An FDA inspection of Buderer Drug Company Inc., a specialty compounding pharmacy in Perrysburg, OH, was conducted from December 14, 2015, to January 4, 2016. The inspection, guided by 21 CFR 211 and industry guidance for sterile drug products, focused on the firm's sterile drug production processes. This initial FDA inspection identified five significant observations documented on an FDA Form 483. Key violations included deficiencies in aseptic processing areas, specifically concerning the placement of lyophilizer entry within an ISO 7 area, necessitating manual transport that could compromise sterility. The firm also lacked adequate environmental and personnel monitoring, failing to perform daily viable air, non-viable air, surface, and personnel testing in the ISO 5 sterile production zone. Furthermore, Buderer Drug Company Inc. could not provide data to support the three-month storage duration of sterilized glassware in an unclassified area or the three-month expiration dating for stock solutions. Critically, the inspection noted the absence of sterility and endotoxin testing for every batch of sterile drug product, including those intended for intrathecal use. Management was cooperative and committed to immediately ceasing the use of the non-compliant lyophilizer. They also pledged to evaluate and correct the remaining issues and provide a written response to the FDA 483 within 15 days.