FDA 483 - AbbVie Inc. - January 31, 2023

Abbvie, Inc. in North Chicago, IL was inspected and received a Form 483 with five observations. The inspection revealed significant issues with laboratory controls, including inadequate investigations into OOS/OOT results and untimely confirmatory testing using expired samples. Additionally, the firm failed to establish scientifically sound specifications, maintain proper quality control unit responsibilities, control cross-contamination, and follow written procedures for equipment cleaning and maintenance.