Concord Biotech’s Dholka Facility: Four USFDA Observations, Countless Opportunities for Compliance

Concord Biotech Limited has released a press release announcing that it has successfully completed a routine USFDA inspection of its Dholka manufacturing plant. The inspection process was carried out between April 28 and May 2, 2025, for five working days. After the process was completed, the USFDA released a Form 483 with four observations.

 

Form 483 is a standard form released by the USFDA to bring out any conditions or practices that can be subject to corrective action upon inspection. The company informed that it will remedy these observations by taking proper corrective and preventive steps, reasserting its intent to uphold high levels of quality and compliance in its operations.

 

Concord Biotech reaffirmed that it will adhere to strict regulatory standards and will work together with the USFDA in close coordination to rectify all the observations at the earliest. The company has a good record of regulatory compliance and continues to export its products to overseas markets, reaffirming its growth trajectory.

 

This achievement comes after earlier successful audits by other international regulatory bodies, further confirming Concord Biotech's dedication to quality production processes.

 

Source: Concord Biotech Limited