FDA Expands Investigation of J&J McNeil Consumer Healthcare
The US Food and Drug Administration has announced that it is expanding its investigation of the Johnson and Johnson McNeil Consumer Healthcare unit after a recent recall of about 50 children’s over-the-counter medications, such as Tylenol, Motrin, and Benadryl. The agency’s inspection of the manufacturing plant in Fort Washington PA has uncovered significant manufacturing practice problems. Issues have also recently occurred at the company’s manufacturing plant in Puerto Rico.
On May 1, the FDA announced a voluntary recall of infant and children’s liquid suspension products due to “manufacturing deficiencies that affected the quality, purity, or potency” of the medications. The medications were said to possibly contain “incorrect concentration of ingredients, ingredients that don’t meet testing requirements, and tiny metal particles.”
The agency then conducted an inspection of the manufacturing plant and issued a 17-page report on May 6th that cited 20 violations. David Lebo, a professor of pharmaceutical manufacturing at Temple University, told CNN that the report was “shocking” and that the FDA found “issue with almost every system at the plant.” The violations included inadequate employee training, “dusty and filthy” conditions, and drums used to transport raw materials that contained bacterial contamination.
The worst violation in the report, according to Lebo, is that the plant did not “maintain adequate laboratory facilities for the testing and approval of components of drug products.” The FDA report also indicated that J&J received 46 consumer complaints between June 2009 and April 2010 on the recalled products but has not yet taken any action.
The Fort Washington facility has been shut down pending McNeil’s internal “comprehensive quality assessment.” The company said in a statement that it “continues to cooperate with the FDA” and they will not restart operations until they have “taken the necessary corrective actions and can assure quality of products made there.”
The May 1st recall was Johnson & Johnson’s fourth in the past 7 months. In November and December 2009, Tylenol Arthritis Pain medications were recalled due to reports of an “unusual moldy, musty, or mildew-like odor” that led to nausea, stomach pain, vomiting and diarrhea. In January 2010, adult medications including Tylenol and Motrin made in the company’s Puerto Rico facility were recalled due to complaints of an “unusual odor”.
The FDA is now conducting a companywide investigation of McNeil’s manufacturing practices “to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur.” In addition, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall. J&J Chief Executive William Weldon will likely testify.