FDA Action Prevents Manufacturing in Certain McNeil Facilities until GMP Requirements Met

March 17, 2011 10:02 AM

Food and Drug Administration (FDA) has taken action against McNeil-PPC in response to the company’s failure to comply with good manufacturing practice (GMP) requirements. As reported in a news release, the agency filed a consent decree of permanent injunction against McNeil-PPC and two of its officers for failing to comply with GMP requirements as required under the federal Food, Drug, and Cosmetic Act, and the action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, PA, facility until FDA determines that its operations are compliant with the law. The company is also required to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, PA, into compliance according to a strict timetable.

As reported in May 13, 2010 e-News, McNeil, working with FDA, initiated a voluntary recall of certain over-the-counter liquid products for children and infants due to manufacturing deficiencies which may affect quality, purity, or potency. FDA notes that such deficiencies have resulted in several extensive recalls. The decree, “requires McNeil to destroy all drugs under McNeil’s control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009.” More details are included the FDA news release. The decree becomes effective when it has been entered by the court.