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) …
Data integrity continues to be one of the main topics during FDA inspections. One of the contributing causes for the warning letter to the American company Vi-Jon was the lack of controls to ensure the integrity of electronic data as well as insufficient access control to IT systems. Based on an inspection which was carried …
Data Integrity Problems as Main Topic of FDA Warning Letter Read More »
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, …
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 …
Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter Read More »
