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 »
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 …
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, …
USFDA Warning Letter of Aurobindo Pharmaceutical Limited 2022 Read More »
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 …
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, …
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 …
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 »
