Aurobindo Pharma unit gets 9 observations from USFDA
New Delhi: Aurobindo Pharma Ltd on Monday said the US Food and Drug Administration (USFDA) has issued nine observations after inspection of its unit 4 formulation facility in Hyderabad.
The USFDA has conducted an inspection at the company’s unit 4, a formulation manufacturing facility in Hyderabad from 12-20 February, Aurobindo Pharma said in a BSE filing. “... at the end of the inspection, we were issued a Form 483 with 9 observations, “ it added.
Aurobindo Pharma shares closed 3.73% lower at Rs600.80 on BSE, while the Sensex closed 0.88% down at 33,746.78 points. In intraday trade, the stocks declined as much as 5.46% to Rs590.
None of the observations are related to data integrity or are repetitive in nature, Aurobindo Pharma said. It, however, did not provide details regarding the observations. “We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20 February) of audit,” it added.
As per the USFDA, a form 483 notifies a company’s management of objectionable conditions at its facility.
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