![]() Analytical worksheets, incident report forms, non-conformance reports, batch release copies, and pre-printed blank forms were stored in laboratory drawers and cabinets with unrestricted access and inadequate controls.Your Quality Unit (QU) failed to ensure adequate document control over paper and electronic records. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Ī. We reviewed your Decemresponse to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.ĭuring our inspection, our investigators observed specific deviations including, but not limited to, the following.ġ. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 75, 76 & 76/1, Chikhloli MIDC, Ambernath-West, Thane – 421501, Maharashtra, from November 14 to November 21, 2022. ![]() Food and Drug Administration (FDA) inspected your drug manufacturing facility, Centaur Pharmaceuticals Private Ltd., FEI 3003973520, at Plot No. ![]() Issuing Office: Center for Drug Evaluation and Research | CDER ![]()
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