FDA 483 - Aphena Pharma Solutions-Maryland LLC - February 20, 2026

Aphena Pharma Solutions - Maryland, LLC, a drug manufacturer in Easton, MD, was cited with three observations during an FDA inspection from February 17-20, 2026. The inspection revealed significant deficiencies in quality control, including inadequate investigations of discrepancies and out-of-specification results, and a failure to follow and maintain written procedures for batch record review and supplier evaluation. These issues indicate a lack of robust quality systems, potentially impacting product quality and integrity.