FDA EIR - Aphena Pharma Solutions - Tennessee LLC - July 22, 2022

An FDA pre-approval reinspection of Aphena Pharma Solutions - Tennessee LLC, a packager, repackager, labeler, and relabeler of human drugs and dietary supplements in Cookeville, TN, occurred from July 19-22, 2022. The inspection was conducted under Compliance Programs 7346.832 (Pre-Approval Inspections) and 7356.002B (Drug Repackers and Relabelers), covering applications for Naproxen Sodium and Cetirizine Hydrochloride. The inspection assessed the company's responses to two observations from a prior inspection in October 2021. These earlier issues involved inadequate control over drug product labeling and equipment not appropriately designed for its intended use. In response, Aphena Pharma Solutions implemented voluntary corrections, including establishing a DEA label storage area, upgrading bottling line equipment through transfers and new purchases, and completing process validation protocols and equipment qualifications for the subject drug applications. During the current assessment, an internal nonconformance was identified concerning the firm's failure to complete environmental monitoring for the fourth quarter of 2021. However, this issue was subsequently investigated, and all later environmental samples passed. Ultimately, the inspection was classified as "No Action Indicated" (NAI), signifying that no new significant regulatory violations were observed, and no FDA-483 observations were issued during this visit.