483
Atlantic Management Resources Ltd.Atlantic Management Resources Ltd. – FDA 483, Aug 10, 2022
Record Details
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.
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ID · f738cc6d-9ce6-4ea8-89f3-6d7109e3f5fa
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