Dr. Reddy's Laboratories Ltd. on Saturday said it has received four observations from the U.S. health regulator U.S. FDA for its facility at Srikakulam in Andhra Pradesh.
“The audit of the company's API Srikakulam Plant (SEZ) by the U.S. drug regulator was completed on Friday and we have been issued a form 483 with four observations,” the Hyderabad-based pharma company said in a regulatory filing, adding that it would address the four concerns within the stipulated timeline.
As per the U.S. health regulator, “A FDA Form 483 is issued to firm management 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 (FD&C) Act and related Acts.”
The FDA Form 483 notifies the company's management of objectionable conditions.
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