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This Article is From Jul 08, 2016

Lupin’s Dabhasa Facility Gets 2 Observations from U.S. Drugs Regulator

The company said both Form 483 observations were minor in nature.

Lupin’s Dabhasa Facility Gets 2 Observations from U.S. Drugs Regulator
Capsules move along the production line at the Lupin Ltd. (Photographer: Dhiraj Singh/Bloomberg) 

Lupin Pharmaceutical's Dabhasa unit, near Vadodara, received two Form 483s from the US health regulator, after thorough inspection from June 29 to July 6, the company said in a filing on the Bombay Stock Exchange (BSE).

Both theobservations are minor in nature and corrective and preventive actions were shown to the inspectors during theinspection. 
Lupin's BSE filing

Form 483 is used by the U.S. Food and Drug Administrator (U.S. FDA) to document and communicate concerns discovered during their inspections, according to the regulator's website.

On Thursday, the U.S. FDA closed the inspection carried out at Lupin's Goa plant in July 2015.

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