Aurobindo Pharma was issued 'Form 484' with two observations at the end of the inspection by US FDA.
The FDA completed its inspection of the Aurobindo Pharma's wholly-owned subsidiary APL Health Care, Unit I and III. This is an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Telangana. Inspection happened from January 9 to January 18, 2023.
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. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. 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.
Following this news, the stock price did not exactly crash but went down from Rs.444 to Rs.441 and is now trading in the green at Rs.445.85.