FDA EIR - Abbvie Biotechnology Ltd. - January 13, 2017

An FDA pre-approval inspection was conducted at AbbVie Biotechnology Ltd.'s facility in Barceloneta, PR, from January 9-13, 2017. The inspection focused on the manufacturing of Vedolizumab drug substance to support a prior-approval supplement, operating under FDA Compliance Programs and ICH Q7 Good Manufacturing Practice guidelines. The inspection resulted in an FDA Form 483 detailing four significant observations. Key issues included inadequate investigations into deviations, specifically regarding recurring low-level microbial contamination (Nectria mauritiicola), where a previous investigation was closed without identifying a root cause or implementing effective corrective actions. The Quality Unit also failed to ensure complete and accurate production batch records; an out-of-specification result for a critical optical density test was not properly investigated, leading to the release of affected drug substance batches, and the firm continued using the impacted component. Furthermore, laboratory procedures for investigating invalid assays were deemed insufficient, and the Vedolizumab drug substance batch record lacked specific filtration process details as recommended by the filter vendor. AbbVie's management acknowledged these observations and committed to submitting a comprehensive written response to the agency outlining their proposed corrective and preventive actions.