Lupin Cited by FDA for GMP Violations

Lupin, a Mumbai, India-headquartered generic pharmaceutical company, has received a Form 483 from the US Food and Drug Administration (FDA) citing three observations on the company’s solid oral dosage facility in Goa, India during an FDA inspection that was completed on April 7, 2017. Lupin is in the process of preparing a response to address the FDA’s observations, Lupin said in a company filing with the Bombay Stock Exchange (BSE).

The citation follows an inspection the FDA conducted of the same facility last year where the agency issued nine observations related to aspects such as inadequacy and adherence to standard operating procedures, according to Lupin in a March 2016 company filing with the BSE.

Lupin’s Goa facility, which began operations in February 2004, manufactures and delivers oral dosage forms with a capacity of more than nine billion units per year. In the past, the facility has been inspected by the FDA six times and by the UK’s Medicines & Healthcare products Regulatory Agency five times, according to the company website.

Source: Bombay Stock Exchange

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