Casper Pharma gets 2 USFDA observations

Maharashtra: Suven Pharma has announced that the United States Food & Drug Administration (US FDA) has completed the surveillance inspection of Casper Pharma Private Limited in Hyderabad, a WOS of the company with two observations.

The inspection took place from July 8, 2024, to July 12, 2024.

"The Company has been issued a Form 483 with two observations, which are procedural in nature. We are committed to addressing these observations within the stipulated timeline," Suven Pharma stated.

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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