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News about "Form 483"
Dr. Reddy's Biologics Facility in Hyderabad Receives USFDA Form 483 with Five Observations
The USFDA has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, with five observations.
Form 483 | 13/09/2025 | By Dineshwori | 123
US FDA Completes Inspection at Aurobindo Pharma's Telangana Unit
The inspection of Aurobindo Pharma’s Apitoria Unit-I facility, conducted from 21-29 August, 2025, concluded with five observations.
Form 483 | 30/08/2025 | By Dineshwori | 182
Dr. Reddy's Srikakulam Facility Gets Form 483 After USFDA Inspection
Dr. Reddy’s Laboratories has received a Form 483 with seven observations from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.
Form 483 | 19/07/2025 | By Dineshwori | 194
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 | 650
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 | 683
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 | 1348
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 | 2729
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 | 748
Ipca Laboratories Ltd receives 8 observations from USFDA for formulations facility at SEZ Indore, Pithampur
Form 483 | 26/06/2023 | By Sudeep Soparkar | 1521
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 | 1299
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