FDA 483 - Atlantic Management Resources Ltd. - August 10, 2022

An FDA inspection of Atlantic Management Resources Ltd. in Westborough, MA, a manufacturer of OTC homeopathic drug products, revealed significant deficiencies across its operations. The firm lacks a functional quality control unit, proper batch production records, and adequate testing for finished products and components. Furthermore, issues were noted with stability testing, labeling procedures, and appropriate storage conditions for drug products and their containers.