FDA 483 - Aprecia Pharmaceuticals LLC - March 21, 2025

The FDA inspected Aprecia Pharmaceuticals, LLC in Mason, OH, and issued a Form 483 with two observations. The inspection revealed deficiencies in component testing, specifically lacking specific identification tests for drug product components, and issues with laboratory records where analysts could manipulate data in Empower software without saving chromatograms. These issues indicate potential concerns with product quality and data integrity.