• 14
  • March
    2011

Last Thursday, the Food and Drug Administration told the consumer-health unit of Johnson & Johnson that one of its Fort Washington plants was barred from continuing operations.

The Fort Washington plant closed last April after an FDA inspection resulted in a number of citations. Among the problems the FDA noted were releasing the incorrect dose of active ingredient into medication batches, allowing bacterial contamination, and allowing metal shards to find their way into medication batches. The plant was reported to have circulated millions of containers of defective medication last year.

The Fort Washington plant was one of three Johnson & Johnson manufacturing sites that were linked last year to several recalls of medication, including Children's Tylenol, Benadryl and Motrin.

FDA apparently signed a formal consent decree with Johnson & Johnson last year, which requires the company to destroy all recalled drugs within 30 days, and to establish third party contractors to inspect the factories and make improvement recommendations. The FDA announcement also noted that that Johnson & Johnson's McNeil Consumer Healthcare unit had produced medicine in violation of federal law, and would be fined as much as $10 million per year unless it complies with the consent decree

The agreement had been filed in U.S. District Court in Philadelphia, and names facilities in Fort Washington, Las Piedras, Lancaster, and Puerto Rico.

Prior to the Fort Washington plant's closing, it employed roughly 400 employees and was responsible for producing most of the Johnson & Johnson's liquid cold medications.

Since September of 2009, Johnson & Johnson has issued 20 recalls on various products, including over-the-counter medicines, contact lenses and hip replacements.

Johnson & Johnson doesn't expect the Fort Washington Post to open till late in 2011. The company plans to invest $100 million in upgrading the Fort Washingotn plant and other McNeil operations.

The Fort Washington plant is to remain closed until the FDA and an independent inspector examine and certify it.

Source: www.philly.com, "FDA cracks down on J&J sites linked to recalls," Matthew Perrone, 11 Mar 2011.