FDA Warning Letter

Warning Letter of Lupin Limited 2022

Lupin Limited MARCS-CMS 633703 — SEPTEMBER 27, 2022 September 27, 2022 WARNING LETTER Delivery Method:Via EmailProduct:Drugs  Recipient: Site Head and Senior General Manager ManufacturingLupin Limited T-142, MIDC Tarapur via Boisar Palghar 401506Maharashtra IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-25 September 27, 2022 Dear Mr. Patel: The U.S. Food and Drug Administration (FDA) […]

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FDA WARNING LETTER – Shilpa Medicare Limited

Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-21-01 October 9, 2020 Dear Mr. Bhutada: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility at Shilpa Medicare Limited,

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Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 23, 2020, to Tender Corporation. The firm manufactures and distributes OTC products. During an inspection from November 12 to 25, 2019, the FDA  investigators observed specific violations of current Good Manufacturing Practice (CGMP). The FDA reviewed the response to the Form

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