USFDA completes audit of Louisiana-based facility with no observations: Dr Reddys

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 Act and related Acts.

New Delhi: Dr Reddy's Laboratories on August 9 said the US health regulator has completed an 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 US Food and Drug Administration (USFDA), 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.

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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 Act and related Acts.

It notifies the company's management of objectionable conditions.

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