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Lupin receives 5 observations from USFDA for Vizag facility

The USFDA inspection for the API facility at Vizag was carried out between January 13, 2020 and January 17, 2020, and it closed five 483 observations

twitter-logo PTI        Last Updated: January 18, 2020  | 23:27 IST
Lupin receives 5 observations from USFDA for Vizag facility

Drug firm Lupin on Saturday said it has received five observations from the US health regulator after inspection of its Vizag facility in Andhra Pradesh.

The inspection of company's Vizag API manufacturing facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in a filing to BSE.

The inspection was carried out between January 13, 2020 and January 17, 2020, it added.

The inspection for the API facility at Vizag closed with five 483 observations, Lupin said.

"We are fully committed to adherence with CGMP regulations and uphold high quality standards across all our manufacturing sites. We are confident of addressing the observations to the US FDA's satisfaction," Lupin MD Nilesh Gupta said.

ALSO READ:Lupin's multiple manufacturing units now under USFDA scanner

ALSO READ:Lupin receives two observations from USFDA after Nagpur facility assessment

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Tags: Lupin | US FDA
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