News about "Form 483"

Strides Receives US FDA EIR for Flagship Facility in Bengaluru

Strides receives the US Food and Drug Administration (FDA) Establishment Inspection Report (EIR) for its flagship Bengaluru facility following a current Good Manufacturing Practice (cGMP) inspection conducted in May 2026.

Form 483 | 20/08/2026 | By News Bureau

Aurobindo Pharma's Raleigh Plant Receives VAI Classification from US FDA

Aurobindo Pharma’s Raleigh plant receives Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (FDA), closing the inspection and allowing pending inhaler and dosage-form applications to progress.

Form 483 | 17/08/2026 | By News Bureau

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 |  225

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 |  231

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 |  840

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 |  730

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 |  739

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 |  982

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 |  860

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 |  1830