Sun Pharma is in the red today, following 10 observations from the US FDA. The stock opened slightly weak at Rs.879.20 and went down to hit an intraday low at Rs.846.35, a fall of almost 4.5%.

The company announced today late morning that the USFDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharma’s Halol facility (Gujarat, India) from April 26 to May 9, 2022.

At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days.

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. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.