FDA EIR - AbbVie Bioresearch Center - May 24, 2018

An FDA inspection of AbbVie Bioresearch Center, Inc. in Worcester, MA, was conducted from May 15-24, 2018. This Level II GMP inspection, performed under Compliance Program 7345.848 for Biological Drug Products regulated by CBER, focused on the Quality, Materials, Production, and Facilities & Equipment Systems. At the inspection's conclusion, a three-item FDA Form 483 was issued, detailing significant observations. Key violations included an inadequate investigation into residue found in a drug substance, leading to the release of a lot without root cause identification or additional testing. The qualification of a new cold room was also found deficient, lacking essential temperature mapping data for "worst-case" scenarios like power failures, and the firm's revised procedures were not retroactively applied. Furthermore, personnel monitoring procedures during aseptic processing were not consistently followed, with an operator compromising a critical component and environmental monitoring samples being processed inadequately. AbbVie management committed to providing a written response to the FDA within 15 business days. The FDA also requested that process changes, such as the use of a (b)(4) and modifications to chromatography column performance evaluation, be formally reported in the company's next annual report, complete with supporting data to demonstrate comparability and efficacy. These actions are crucial for ensuring ongoing compliance with good manufacturing practices.