Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
Drug Approval

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

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

  • By IPP Bureau | March 05, 2025

The United States Food and Drug Administration (USFDA) conducted an inspection at Unichem Laboratories Ltd's Pithampur API facility from 24th February 2025 to 28th February 2025.

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

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

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