Aurobindo Pharma’s formulation manufacturing facility at Bachupally, Hyderabad has been issued a Form 483 with six observations by the US Food and Drug Administration (USFDA).
The facility was inspected by the regulator from April 10 to 18 and at the end of the inspection “we have been issued a Form 483 with six observations”, the company said on Wednesday. The observations are all on procedural improvements and none of them relate to data integrity, Aurobindo Pharma informed the stock exchange. Noting that it will be responding as per the prescribed timelines, the company said, “There is no material impact of the observation on the company.”
Form 483 is issued by the regulator “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 Act and related Acts.” Through its issue, the company’s management is notified of the objectionable conditions.
Share prices
Aurobindo Pharma share prices on Wednesday closed at ₹ 640.20, down ₹ 23.40 apiece or 3.53 % compared to the previous close.
