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US FDA makes 3 observations after inspecting Dr Reddy's UK plant

Form 483 issued to the firm's management over violation of regulatory norms

Press Trust of India  |  New Delhi 

Dr Reddy's

Pharmaceutical company Dr Reddy's Laboratories on Friday said the US health regulator has made three observations after inspecting its facility.

The audit of in the by the US Food and Drug Administration (FDA) was completed on Friday, Dr Reddy's said in a regulatory filing to stock exchanges.

"We have been issued a with three observations, which we are addressing," it added.

As per the US FDA, "FDA is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related acts".

First Published: Fri, September 15 2017. 23:49 IST
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