Sun Pharma's shares fell nearly 2 per cent on Tuesday. The USFDA on Friday issued Form 483 with 11 observations after inspection of the company's Dadra facility during March 22-29.
An FDA Form 483 is issued to a firm's management 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.
The company says it has submitted its response to the USFDA within the stipulated timeline.