Healthcare News & Insights

FDA blasts quality control at McNeil plant

More than 20 different problems with manufacturing and quality control processes at a major pharmaceutical plant were outlined in a report just released by the FDA.

The McNeil Consumer Healthcare plant, in Fort Washington, Pennsylvania, has been under a spotlight since 43 different Johnson & Johnson medications were recalled. The medications, including children’s formulations for Tylenol, Motrin, Zyrtec and Benadryl, were found to be contaminated with gram negative bacteria.

The FDA report (download) following the recall said the plant was dirty, had inadequate quality-control procedures and didn’t adhere to the procedures it did have in place.

The plant has been shut down by the company indefinitely. The FDA hasn’t said if it will take further action.

Health care experts and consumer advocates are using the recall to call for tighter pharmecutical manufacturing standards.

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  1. […] plants have had a series of quality problems in the recent past, and questions have been raised over how the company has handled the issue. […]