FDA Warning Letter

USFDA Warning Letter of Indiana Them-port 2022

Indiana Chem-Port MARCS-CMS 618173 — FEBRUARY 02, 2022 February 02, 2022 WARNING LETTER Delivery Method:Via EmailProduct:Drugs  Recipient:Indiana Chem-Port 349 GIDC Industrial Estate Makarpura, Vadodara Gujarat IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-11 AMENDED February 2, 2022 Dear Mr. Desai: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indiana …

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USFDA Warning Letter of Aurobindo Pharmaceutical Limited 2022

Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs  Recipient:Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy DistrictHyderabad 500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January 12, …

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USFDA Warning letter for Biotek India

Biotek India MARCS-CMS 613295 — MAY 13, 2021 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs  Recipient:Biotek India  919/2 First Floor, Conmet Cross Road, Makarpura GIDC Vadodara 390010 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research United States Warning Letter 320-21-45 May 13, 2021 Dear Mr. Arora: Your facility is registered with the United States Food and Drug Administration (FDA) as a …

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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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WARNING LETTER

Pfizer Healthcare India Private Limited Warning Letter 2020 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pfizer Healthcare India Private Limited, FEI 3008316085, at Plots 116-117-118-119-111-123 (part), Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam, Andhra Pradesh, India, from August 29 to September 6, 2019. This warning letter summarizes significant violations of current …

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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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