Date:07/05/2004 URL: http://www.thehindubusinessline.com/2004/05/07/stories/2004050702060200.htm

Back USFDA inspects Divi's Labs facility

Our Bureau

Hyderabad , May 6

DIVI'S Laboratories Ltd has announced that its manufacturing facility located at Choutuppal near here was inspected by the US Food and Drug Administration (USFDA) during the first week of this month.

According to a company's press release, the USFDA had expressed that the findings were acceptable and the company received no `483' comments/observations.

According to the company, a 483 is given to any company when there are objectionable findings or deficiencies with the facilities or systems for compliance.

The current FDA inspection includes the pre-approval for Levetiracetam. The prior inspection of the facility of the company in the year 2000 was for six drug master files (DMFs) for marketing its products in the US market. The company currently has 12 DMFs for the US market, the release said.