Scientific Laboratories, a contract firm operating in Columbia, Maryland, has been sanctioned by the FDA and has entered into a consent decree prohibiting it from engaging in commercial operations (manufacture and sales). Scientific Laboraties is run by Amit Roy and Rajeshwari Patel.
Scientific Laboraties has failed FDA inspections over the last several years and its products have failed to meet standards for good manufacturing practice requirements (CGMP).
The case looks remarkably similar to that of Able Laboratoires several years ago. There seems to be a growing trend of individuals moving from India and starting up small manufacturing facilities in the U.S. to produce generic drugs and OTC products.
While there are problems at manufacturing facilities oversees, there are also problems at firms here in the U.S.