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

An FDA inspection of Aphena Pharma Solutions - Maryland, LLC in Easton, MD, revealed significant deficiencies in quality control and investigation processes. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, and its Quality Assurance unit did not adequately verify batch record accuracy. Additionally, the company lacked procedures to evaluate raw material and component suppliers, contributing to persistent hair contamination in drug products.