Dr Reddy's gets 1 observation from USFDA for formulation plant
New Delhi, Feb 28 () Dr Reddy's Laboratories on Friday said the US health regulator has issued a Form 483 with one observation after inspecting one of its formulation plants in Hyderabad.
Earlier in the day, the drug major had said that the US health regulator has issued a Form 483 with two observations after inspecting the facility.
"We wish to inform you that the US Food and Drug Administration (USFDA) investigator has subsequently issued a revised Form 483 with one observation only, in place of two observations intimated earlier," Dr Reddy's Laboratories said in a regulatory filing.
The company will address the said observation comprehensively within the stipulated timeline, it added.
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.