Sun Pharmaceutical Industries, a Mumbai, India-headquartered specialty generic pharmaceutical company, has received a Form 483 listing 11 observations from the US Food and Drug Administration for its formulation facility in Dadra, India. The observations were cited during the FDA’s inspection of the Dadra facility on April 13, 2017. Sun Pharma is in the process of responding to the FDA within the stipulated timeline of 15 days, according to Sun Pharma in a filing with the Bombay Stock Exchange.

The Dadra facility, which began commercial production in March 2002, has a capacity of 2.4 billion tablets per year, according to Sun Pharma. The facility manufactures solid oral dosage forms (tablets, capsules).

Source: Bombay Stock Exchange