FDA 483 - Carnegie Pharmaceutical Llc - June 29, 2021

An FDA inspection of Carnegie Pharmaceuticals, LLC in Delran, NJ, revealed significant deficiencies in quality control and manufacturing practices. Observations included failures to follow written procedures for component identification, inadequate establishment of test method accuracy and sensitivity for impurities, and insufficient laboratory controls for pH meter calibration and temperature monitoring. These issues indicate a lack of assurance in drug product quality and purity.