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News about "Form 483"
USFDA Completes Inspection of Indoco API Plant in Patalganga with Zero Observations
The inspection of Indoco’s API manufacturing facility at Patalganga by the US FDA concluded with zero form 483 observations.
Form 483 | 22/09/2025 | By Dineshwori
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 | 292
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 | 324
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 | 339
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 | 699
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 | 733
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 | 1459
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 | 3012
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 | 818
Ipca Laboratories Ltd receives 8 observations from USFDA for formulations facility at SEZ Indore, Pithampur
Form 483 | 26/06/2023 | By Sudeep Soparkar | 1714
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