Express Pharma

US FDA completes audit of Dr Reddy’s Louisiana-based facility

No Form 483 was issued at the end of the inspection, the company said in a regulatory filing, the company said

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Dr Reddy’s Laboratories announced 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 (US FDA), has been completed on August 8, 2019. No Form 483 was issued at the end of the inspection, the company 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 judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts. It notifies the company’s management of objectionable conditions.

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