483
Newton Laboratories, Inc.FDA 483 - Newton Laboratories, Inc. - September 17, 2021
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Record Details
An FDA inspection of Newton Laboratories, Inc. in Conyers, GA, a homeopathic drug establishment, revealed a significant quality system deficiency. The firm's quality control unit failed to fully follow its change control procedures, implementing several changes without proper documentation, evaluation, or approval. This issue is a repeat observation from a previous FDA 483.
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ID · d1a4aea2-af5d-40ea-88f9-3e3ab729ca09