Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
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Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

  • By IPP Bureau | June 23, 2025

The United States Food and Drug Administration (USFDA) conducted an inspection at Unichem Laboratories Ltd's Roha API facility from 16th June 2025 to 20th June 2025.

The inspection closed with three observations which were more of procedural changes with none of these related to data integrity.

The company will provide the necessary response to USFDA within stipulated 15 days.

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