FDA EIR - AbbVie Ltd - December 21, 2018

An FDA inspection of Abbvie LTD in Barceloneta, PR, was conducted from December 12 to December 21, 2018. This inspection was performed under Compliance Program 7356.002 for Drug Manufacturing Inspections and 7356.021 for Drug Quality Reporting. The review encompassed quality, laboratory, packaging, labeling, facilities, equipment, production, materials systems, and complaint investigations. Notably, the current inspection resulted in "No Observations Issued" and was classified as No Action Indicated (NAI), signifying compliance at the time of inspection.

The primary focus of this inspection was to assess the company's corrective actions in response to significant observations identified during a previous inspection in July 2016. Main issues from the prior inspection included: a failure to maintain microbial release records for validation lots; inadequate evaluation of field and retain samples related to a product complaint reporting brown spots; an absence of a stability test method for impurities and degradants in Divalproex Sodium Tablets; incomplete documentation of warehouse mapping studies; and inadequate cleaning procedures for verification of cleaning activities. A verbal observation also noted incomplete documentation in some exception reports.

Abbvie LTD implemented various voluntary corrections to address these findings. Actions included revising procedures for complaint investigations (SOP QPP07-01-004), enhancing warehouse mapping study documentation (SOP QPP04-01-001-APL 1), and improving cleaning verification processes (SOP BOP.P-K002) to include visual inspections. The firm also clarified that a stability method for impurities in Divalproex Sodium was not required per its NDA. The investigator concluded that the exception reports were now adequately documented. The outcome reflects successful remediation of previous issues.