FDA 483 - Premier Trends LLC - September 29, 2021

An FDA inspection of Premier Trends LLC in Monroe Twp, NJ, revealed significant and repeat deficiencies in its manufacturing of OTC drug products and topical skincare preparations. The firm lacked written procedures for its quality control unit, failed to provide cGMP training to personnel, and maintained deficient batch production records. Additionally, the inspection found that drug products were not adequately tested before release, and equipment calibration was not performed according to a written program, indicating serious non-compliance with good manufacturing practices.