Dr Reddy's Gets Form 483 With Seven Observations From USFDA After Inspection At Andhra Unit
The inspection was conducted at Dr Reddy's formulations facility in Andhra Pradesh from July 10 to July 18.
Dr Reddy's Laboratories Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the United States Food & Drug Administration following an inspection, according to an exchange filing on Friday.
The American drug regulator completed a good manufacturing practice and a pre-approval inspection at the firm's formulations manufacturing facility in Srikulam, Andhra Pradesh, the filing stated.
"The inspection was conducted from 10th July to 18th July, 2025. We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline," the company said.
An FDA Form 483 is issued at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, the regulator states on its website.
The observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any drug has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health, the website further says.
The Form 483 does not, however, constitute a final ruling from the agency on whether the conditions are violating any of their regulations.
Before the development was notified to the exchanges, shares of Dr Reddy's closed 0.44% lower at Rs 1,257.5 apiece on the National Stock Exchange, compared to a 0.57% decline in the benchmark Nifty. The stock has fallen 5.7% in the last 12 months and by 9.7% on a year-to-date basis.
Out of 40 analysts tracking the company, 17 have a 'buy' rating on the stock, 10 recommend 'hold' and 13 suggest 'sell', according to Bloomberg data. The average of 12-month analysts' price target implies a potential upside of 0.5%.
