FDA针对于Dr Reddy's的Telangana原料药工厂签发了含4条observations的483

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Dr Reddy's gets 4 observations from USFDA for Telangana plant

Pharmaceuticals-Healthcare/Biotech-Industry-The Economic Times / 2018-03-16 20:01


NEW DELHI: Drug major Dr Reddy's Laboratories today said the US health regulator had issued four observations after inspecting its active pharmaceutical ingredients (API) facility in Telangana.
"The audit of our API Hyderabad plant 1 at Jinnaram Mandal, Medak district, Telangana, by the USFDA has been completed today. We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time," Dr Reddy's said in a regulatory filing.

As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement 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 shares were trading 1.71 per cent down at Rs 2145.95 on the BSE.

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