FDA Requires Federal Oversight of J&J Plants After String of Drug Recalls

Federal regulators have put an injunction in place against Johnson & Johnson’s over-the-counter (OTC) drug division following a seemingly endless string of quality control problems and drug recalls.  

Under a consent decree revealed yesterday by the FDA, McNeil Consumer Healthcare will not be able to manufacture or distribute any drugs from its Fort Washington, Pennsylvania factory until the federal inspectors can confirm that the plant is fully compliant with the law.

The J&J subsidiary will have to endure federal oversight of its Fort Washington facility, and problem-plagued plants in Lancaster, Pennsylvania and Las Piedras, Puerto Rico.

The consent decree was filed by the U.S. Department of Justice (DOJ) Office of Consumer Litigation, and the U.S. Attorney’s Office for the Eastern District of Pennsylvania in the U.S. District Court. In addition to McNeil, the decree also names Veronica Cruz and Hakan Erdemir, both high-ranking McNeil executives, as defendants.

The Fort Washington plant has been closed for about a year, following the fallout from a massive recall of children’s liquid medications that affected 40 different liquid medications, including Motrin, Tylenol, Benadryl and Zyrtec. Repeated inspections at the three plants have consistently revealed ongoing quality control problems and have resulted in tens of millions of Johnson & Johnson products being recalled.

As part of the consent decree, McNeil must destroy all drugs manufactured at the three facilities since December 2009. The company has to hire independent experts on Current Good Manufacturing Procedures (CGMPs) to oversee rehabilitation of all three plants and bring them into compliance with FDA standards. The company must also pay all of the FDA’s employee, laboratory and mileage expenses.

If the company continues to fail to comply it could be fined up to $10 million a year and could be prevented from making any of its OTC drugs. The first inspections are likely to occur at the Fort Washington plant within 60 days and at the Las Piedras and Lancaster plants within 150 days.

National attention was focused on Johnson & Johnson’s OTC drugs after an April recall of Tylenol, Benadryl and Motrin, which affected affected 136 million bottles of children’s medications. That recall resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant and the suspension of the production of all children medications manufactured by their McNeil subsidiary.

The ongoing problems with Johnson & Johnson,  have resulted in Congressional hearings and have increased the likelihood that the FDA will receive increased powers to regulate drug makers. There have also been a number of Johnson & Johnson class action and individual lawsuits filed as a result of the ongoing problems.