FDA bans API plant of India's Megafine Pharma

The FDA last week added Megafine Pharma's plant in Lakhamapur, Maharashtra, in India to its import alert list, banning all of its drug products from entering the U.S. According to Regulatory Focus, the facility received a 13-page Form 483 in May that cited it for a number of problems, many having to do with drug testing integrity. There are about 45 Indian facilities on the list. Story | More