AbbVie Inc. – FDA EIR, Feb 15, 2019

An FDA inspection was conducted at AbbVie, Inc. in North Chicago, IL, from February 11 to February 15, 2019. This surveillance inspection, part of the bioanalytical BioResearch Monitoring (BIMO) program, aimed to evaluate the firm’s bioanalytical operations, including method validation and sample analysis for specific studies. A key outcome of this inspection was that no Form FDA-483, Inspectional Observations, was issued, indicating compliance with regulatory standards. The current inspection also served to review the effectiveness of corrective actions taken by AbbVie following a previous FDA inspection in February 2016. The prior inspection resulted in three observations. These included a failure to use freshly prepared standards and quality controls in certain method validation stability experiments, inadequate evaluation of bioanalytical method selectivity concerning interference between analytes and internal standards, and insufficient security for study sample storage in freezers located in an unsecured common area. AbbVie, Inc. had implemented comprehensive corrective and preventive actions in response to these past issues. During the 2019 inspection, FDA investigators confirmed that AbbVie repeated affected experiments, updated relevant Standard Operating Procedures to ensure proper method validation and interference assessment, and significantly enhanced physical security measures for sample storage, including a new freezer room with restricted access and card readers. All previous observations were found to be adequately addressed, demonstrating the company's commitment to quality and regulatory compliance.