Buderer Drug Company Inc – FDA EIR, Jan 4, 2016

An FDA inspection of Buderer Drug Company Inc., a pharmacy producing sterile and non-sterile drugs in Perrysburg, OH, took place from December 14, 2015, to January 4, 2016. The inspection, guided by regulatory framework 21 CFR Part 211 and the "Sterile Drug Products Produced by Aseptic Processing" guidance, focused primarily on the firm's sterile drug manufacturing processes. Five significant issues were identified and documented on an FDA Form 483. Key violations included improper design of aseptic processing areas, specifically related to the entry point for certain equipment, and insufficient daily environmental monitoring in the ISO 5 sterile compounding zone. Additionally, the company lacked supporting data for the storage duration of glassware utilized in sterile product manufacturing and for the three-month expiration dates assigned to critical stock solutions. A major concern was the absence of routine sterility and endotoxin testing for every batch of sterile drug product produced, including those intended for intrathecal administration. As required actions, Buderer Drug Company Inc. immediately committed to discontinuing the use of the improperly located equipment entry and pledged to rectify all other identified deficiencies, providing written responses within 15 days for each observation.