OneSource Specialty Pharma updates on cGMP inspection by USFDA
Drug Approval

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations

  • By IPP Bureau | April 01, 2025

OneSource Specialty Pharma Limited has announced that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the Unit 2 Facility of OneSource Specialty Pharma Limited, located at Doddaballapura, 3rd Phase, Industrial Area, Bangalore, from March 20, 2025, to March 28, 2025.

The inspection has concluded with four observations. The company will respond to these observations comprehensively to FDA within the stipulated time frame.

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