Casper Pharma Hyderabad facility concludes USFDA inspection with zero observations
Hyderabad: Suven Pharmaceuticals Ltd has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at Casper Pharma Private Limited formulations manufacturing facility situated at GMR Hyderabad SEZ, a wholly owned subsidiary of Suven Pharmaceuticals Limited Hyderabad, India.
The inspection was conducted from July 25th through Jul 29th, 2022.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
We are glad to have completed the audit successfully with Zero observations and at the end of the inspection no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations says Venkat Jasti, Managing Director of Suven Pharmaceuticals Limited.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Suven Pharmaceuticals Limited, a company incorporated in November 2018, has become Wholly Owned Subsidiary of Suven Life Sciences Limited, effective February 2019.
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