FDA EIR - AbbVie Bioresearch Center - November 18, 2019

An FDA inspection of AbbVie Bioresearch Center, Inc. in Worcester, MA, was conducted from November 4 to November 18, 2019. This Good Manufacturing Practice (GMP) inspection, part of the Compliance Programs 7356.002M for Licensed Biological Therapeutics Drug Products, focused on the company's Quality, Materials, Facilities and Equipment, and Laboratory Systems. The inspection concluded without the issuance of a Form FDA 483, indicating no significant non-compliance observations. However, several important discussion points were raised with management. These included the need to fully assess airflow interaction between ISO 5 biosafety cabinets and the surrounding ISO 7 room during dynamic smoke studies, especially concerning adjacent equipment. Concerns were also noted regarding the control of GMP records, specifically the ability for personnel to delete data from laboratory computer terminals and the broad accessibility of un-controlled GMP documentation on a shared network drive. Lastly, sampling procedures for certain bulk materials lacked specific guidance on sampling locations within containers. AbbVie management committed to addressing these observations through planned recertifications, updating procedures, and personnel training. The inspection confirmed previous corrective actions from 2017 and 2018 inspections were adequate.