By: IPP Bureau
Last updated : May 03, 2025 1:16 pm
These observations are procedural in nature and none of them are related to data integrity
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.