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News about "Form 483"
Aurisco's Manufacturing Site in China Clears FDA Inspection
Aurisco's Manufacturing Site in China Clears FDA Inspection
Form 483 | 24/08/2023 | By Sudeep Soparkar | 514
Successful FDA inspection at Auriscos manufacturing site in Yangzhou, China
Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China
Form 483 | 16/08/2023 | By Sudeep Soparkar | 564
Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA
Dr. Reddy’s API plant in Hyderabad gets EIR from U.S. FDA
Form 483 | 08/08/2023 | By Sudeep Soparkar | 910
Aurobindo Pharma Ltd gets 3 observations from USFDA for Unit 3 at Bachupally Village
Aurobindo Pharma Ltd gets 3 observations from USFDA for Unit 3 at Bachupally Village
Form 483 | 24/07/2023 | By Sudeep Soparkar | 1893
US FDA Inspection at Pashmylaram Facility, Hyderabad of Gland Pharma Ltd
US FDA Inspection at Pashmylaram Facility, Hyderabad of Gland Pharma Ltd
Form 483 | 28/06/2023 | By Sudeep Soparkar | 552
Ipca Laboratories Ltd receives 8 observations from USFDA for formulations facility at SEZ Indore, Pithampur
Form 483 | 26/06/2023 | By Sudeep Soparkar | 1031
Ipca Laboratories Ltd gets Form 483 with 11 observations for API manufacturing facility at Ratlam
Ipca Laboratories Limited has announced that the US FDA conducted the inspection of the Company's APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th June, 2023 to 13th June, 2023. At the conclusion of the inspection, the US FDA issued a Form 483 with 11 (eleven) observations.<br />
Form 483 | 14/06/2023 | By Sudeep Soparkar | 931
Belgium's UCB Pharma hit with FDA Form 483 after April inspection
UCB Pharma, a Belgium-based biopharma company, has been slapped with a Form 483 from the FDA following an inspection that uncovered issues with its quality control unit and product storage.
Form 483 | 31/05/2023 | By Sudeep Soparkar | 507
US FDA conducts Pre-Approval Inspection of oral oncology manufacturing facility in Gujarat
The company has been issued a Form 483 with 1 observation, which is procedural
Form 483 | 20/03/2023 | By Sudeep Soparkar | 625
US FDA issues Form 483 to Alembic's Jarod facility
None of the observations is related to data integrity and management believes that they are addressable
Form 483 | 20/12/2022 | By Sudeep Soparkar | 655
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