Last Updated on November 11, 2024 by The Health Master
Ahmedabad: Cadila Pharmaceuticals announced that its Dholka manufacturing facility has successfully passed the US Food and Drug Administration’s (USFDA) audit again.
The company’s Dholka manufacturing facility got no Form 483 observations. Form 483 is often served by the USFDA after finding anomalies in its audit.
Nil 483 observations signify compliance and conformance to applicable current good manufacturing practise (cGMP) regulations enforced by the USFDA.
USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7.
While highlighting that 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, Dr Rajiv I. Modi, Chairman and Managing Director of Cadila Pharmaceuticals, said:
“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.”
“I also take this opportunity to congratulate our team at the Dholka facility.”
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, considered to be the world’s largest and most stringent drug market.
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