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Dr Reddy's Laboratories Ltd on Thursday said the US health regulator has issued Form 483 with two observations after inspecting its manufacturing facility located at Srikakulam in Andhra Pradesh.
As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The US Food and Drug Administration (USFDA) completed a pre-approval inspection at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh on Thursday, Dr Reddy's said in a regulatory filing.
The inspection was conducted from June 30, 2022 to July 7, 2022.
"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the company added.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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First Published: Thu, July 07 2022. 21:40 IST