Sunday, 18 August 2019

USFDA completes audit of Dr Reddy's US based plant

12 August 2019 | News

Dr Reddy's Laboratories said the US Food and Drug Administration (FDA) has completed audit of its Louisiana-based formulations manufacturing facility on August 8

Dr Reddys Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. The company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr Reddys operates in markets across the globe.

Dr Reddy's Laboratories said that the US health regulator has completed audit of its Louisiana-based formulations manufacturing facility, following which no form 483 was issued.

The audit of our formulations manufacturing facility at Shreveport, Louisiana, USA by the the US Food and Drug Administration (USFDA), has been completed on August 8, 2019. 

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 judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

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