U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
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U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily

  • By IPP Bureau | September 20, 2021

Lupin has announced that the U.S. FDA has concluded an inspection at its Goa facility in India. The inspection was carried between September 6-18, 2021 and closed with seven observations.

"We wish to inform you that the U.S. FDA has concluded an inspection at our Goa facility in India. The inspection was carried out from September 6, 2021, to September 18, 2021, and closed with seven observations," Lupin said.

The company added it was confident of addressing the observations satisfactorily.

Lupin is "committed to be compliant with Good Manufacturing Practice standards across all our facilities", added the regulatory filing, which was issued under the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Notably, Lupin's Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore had received U.S. FDA's warning letter in November 2017.

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