Amerisource Health Services LLC – FDA EIR, May 27, 2022

An FDA inspection of Amerisource Health Services LLC, operating as American Health Packaging (AHP) in Columbus, OH, was conducted from May 25-27, 2022. The inspection found no conditions warranting an FDA Form 483, indicating a high level of compliance and cooperative management. However, two key discussion items were noted during the close-out meeting, referencing Good Manufacturing Practices (GMP) and current FDA guidance on Field Alert Reports (FARs).

The primary issues involved the timeliness of Field Alert Reports and contract laboratory investigations. AHP had exceeded the required three-day reporting timeframe for three of ten FARs reviewed, mainly due to communication delays with contract laboratories. AHP also acknowledged that third-party laboratory investigations into Out-of-Specification (OOS) results were not completed promptly.

Required actions include AHP developing a Field Alert Report Standard Operating Procedure (SOP) to clearly define notification responsibilities and timeframes in line with the "Field Alert Report Submission Questions and Answers Guidance for Industry" (July 2021). Additionally, quality agreements with application holders must be reviewed and updated to ensure proper FAR reporting obligations. AHP committed to addressing investigation timelines, potentially by changing contract laboratories.