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Dr Reddy’s gets four observations from USFDA for Andhra plant


Dr Reddy’s gets four observations from USFDA for Andhra plant

“The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 4 observations, which we are addressing,” Dr Reddy’s said in a regulatory filing.

Hyderabad: Dr Reddy’s Laboratrories recently said the US health regulator has issued four observations after inspecting its formulations unit in Andhra Pradesh.

“The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 4 observations, which we are addressing,” the Hyderabad-based company said in a regulatory filing.

Read Also: Dr Reddy’s launches Aspirin and Dipyridamole capsules in US market

As per the 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.

It notifies the company’s management of objectionable conditions.

Dr Reddy’s Laboratories is an Indian multinational pharmaceutical company based in Hyderabad, Telangana, India. The company was founded by Anji Reddy, who previously worked in the mentor
institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.



Source: With input
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