The U.S. Food and Drug Administration has issued a form 483 with 11 observations to Aurobindo Pharma Ltd.’s Unit 16 in Telangana, which makes sterile drug products.
The drug regulator had inspected the unit between Feb. 22 and March 1. The unit had received a form 483 containing three observations in May last year.
Not providing adequate training to employees in an observation pertains to procedural lapses, among others.
After the news broke out, the share price of Aurobindo Pharma limited dropped hard by 6.25 percent during the Wednesday trading session. The stock price on Wednesday closed at Rs. 767.00 as compared to the previous close of Rs. 773.25 on NSE.
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