FDA 483 - Medinatura New Mexico, inc. - December 18, 2019
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Medinatura Inc. in Albuquerque, NM, was inspected by the FDA from December 9-18, 2019. The inspection revealed significant deficiencies in quality control, laboratory operations, and record-keeping practices, indicating a lack of adherence to cGMP regulations. These issues include failures in component rejection, supplier qualification, discrepancy investigations, adherence to specifications, complaint handling, and batch record integrity, posing potential risks to drug product quality and patient safety.
ID · 9820eecf-e3d6-4158-b28e-0918e16ffdbc