FDA 483 - PharmaLegacy Research LLC - June 06, 2025

An FDA inspection of Pharmalegacy Research LLC, a non-clinical laboratory in San Diego, CA, revealed significant deficiencies across multiple areas. The firm was cited for failures in quality assurance, proper labeling and retention of test articles, equipment maintenance, and facility suitability. These observations indicate a lack of adherence to established procedures and good laboratory practices.