Cadila Pharmaceuticals Dholka Facility Clears USFDA Audit
The Dholka manufacturing facility of Cadila Pharmaceuticals has successfully cleared the US Food and Drug Administration (USFDA) audit, the company informed on Wednesday.
The Dholka manufacturing facility passed the USFDA audit with nil 483 observations, which signifies compliance and conformance to applicable Current Good Manufacturing Practice (cGMP) regulations enforced by the USFDA. USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7.
“We are pleased that our Dholka manufacturing facility has cleared the USFDA inspection with nil 483 observations. In all our facilities, quality control is inbuilt at every step in the design and manufacturing process. The successful completion of the USFDA audit is a strong validation of our commitment to ensure the availability of medicines that meet the most stringent global quality standards. I also take this opportunity to congratulate our team at the Dholka facility,” said Dr. Rajiv I. Modi, Chairman & Managing Director of Cadila Pharmaceuticals.
Clearing the USFDA audit with nil 483 observations means Cadila Pharmaceuticals can continue to export its medicines made at the Dholka manufacturing facility to the US, the world’s largest and most stringent drug market.
