USFDA inspection at Concord Biotech’s API facility at Dholka
Drug Approval

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity

  • By IPP Bureau | May 03, 2025

Concord Biotech Limited has announced the completion of the inspection of its API facility at Dholka. The inspection took place from April 28 to May 2, 2025.

At the conclusion of the inspection, the USFDA issued Form 483 with four observations. According to the company, these observations are procedural in nature and none of them are related to data integrity.

The company states that it will provide a detailed response to the USFDA within the required timeframe and is confident of addressing the observations expeditiously.

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