U.S. Drug Regulator Issues Observations To Dr. Reddy’s, Lupin
Indian drug makers Dr. Reddy’s Laboratories Ltd., and Lupin Ltd. on Friday said that they have been issued observations by the U.S. Food and Drug Administration (FDA).
Dr Reddy's said it has received 11 observations for its manufacturing plant in Hyderabad. The observations were mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems, the company said in its exchange filing.
Earlier this month, the U.S. FDA issued Dr. Reddy’s two observations after inspecting company's manufacturing plant at Srikakulam in Andhra Pradesh.
The drug regulator also issued Form 483 to Lupin's Goa facility citing three observations. "Recently the company's Goa manufacturing facility underwent an inspection by the U.S. FDA...the inspection was completed on April 7," Lupin said in an exchange filing. The company is in the midst of putting together a response to address the said observations, it added.
A Form 483 is issued if the U.S. drug regulator’s investigators spot any conditions that in their judgment may constitute a violation of the U.S. Food Drug and Cosmetic Act, according to information on the regulator’s website.
With inputs from PTI