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Results For "Form-483"

117 News Found

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility
Drug Approval | February 05, 2026

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain


Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA
Drug Approval | December 26, 2025

Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA

These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products


Briefs:  APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
Drug Approval | December 20, 2025

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma
News | December 06, 2025

Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur


Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
Drug Approval | November 24, 2025

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia


Marksans Pharma's Goa unit clears FDA inspection
News | November 10, 2025

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation


FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval | September 19, 2025

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations


FDA completes inspection at Biocon Biologics' facility in Bengaluru
News | September 05, 2025

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations