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News about "Form 483"
US FDA Clears Anuh Pharma Facility with No Form 483 Observations
The Tarapur facility of Anuh Pharma is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate block with total capacity of 2400 MTPA.
Form 483 | 11/02/2026 | By News Bureau
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 | 166
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 | 492
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 | 518
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 | 521
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 | 779
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 | 787
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 | 1577
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 | 3522
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 | 894
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