"The company had an audit conducted by the United States Food & Drug Administration (USFDA) at the SEZ formulations facility situated at Jadcherla, near Hyderabad, from July 18, 2016 to July 26, 2016," Shilpa Medicare said in a filing to BSE.
The company has not received Form 483 for the above mentioned facility, it added.
An FDA Form 483 is issued to the management of a firm at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.