FDA 483 - Premier Trends LLC - June 28, 2019

Premier Trends, a drug manufacturer in Monroe Twp, NJ, was inspected by the FDA, revealing numerous significant deficiencies across its quality, production, and laboratory systems. The inspection highlighted a severe lack of fundamental Good Manufacturing Practices, particularly concerning their Magic Heal drug product. Key issues include the absence of written procedures for critical operations, inadequate employee training, lack of equipment qualification and calibration, and insufficient product testing and stability programs.