FDA 483 - Prime Matter Labs - September 01, 2023

Prime Matter Labs in Hialeah, FL, was inspected and received a Form 483 with five observations highlighting significant deficiencies in their manufacturing operations. The inspection revealed issues with laboratory controls, facility maintenance, production process validation, reprocessing procedures, and the investigation of discrepancies. These findings indicate a lack of adherence to good manufacturing practices, potentially impacting the quality and purity of drug products.