Dr Reddy’s Laboratories’ Srikakulam Plant Gets Form 483 from US Health Regulator

New Delhi: Dr Reddy’s Laboratories Ltd on Thursday informed that the US health regulator has inspected its manufacturing facility located at Srikakulam in Andhra Pradesh and issued Form 483 with two observations. The inspection was carried out from June 30 to July 7, 2022.

Dr Reddy's said in a regulatory filing that US Food and Drug Administration (USFDA) concluded a pre-approval inspection at the company's formulations manufacturing facility FTO 11 in Srikakulam on Thursday. 

“We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,” the company said.

What is Form 483 and why is it issued?

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 judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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When an investigator has noticed any situations that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, an USFDA Form 483 is dispatched to the company after the completion of an inspection at the facility. The management of the company is notified of unacceptable conditions through USFDA Form 483 and the company is expected to take corrective actions. 

(With inputs from PTI)