Johnson & Johnson is again facing FDA scrutiny after a Lancaster, Pa., plant failed to achieve satisfactory results for regulation compliance.
The Pennsylvania plant received a “Form 483,” according to CNNMoney. The form is issued after an FDA inspection shows problems, including violations of good manufacturing practices and regulatory compliance. The form is not available on FDA.gov yet.
The Lancaster facility is operated by Johnson & Johnson-Merck Consumer Pharmaceuticals and reportedly makes non-perscription products like Imodium, Mylanta, and Pepcid.
This is not the first time a Johnson & Johnson manufacturing facility has received a Form 483.
We previously reported in late May, a Fort Washington, Pa., plant operated by J&J’s drug-making unit McNeil Consumer Healthcare, received a 17-page Form 483, depiciting deplorable conditions, such as holes in the ceiling, lack of training of temporary and contract employees, and a lack of sanitation.
Last Thursday, a mass layoff of hundreds of workers at the Fort Washington plant was announced, where it was reported all production had been suspended as a result of the above Form 483.
In January, a warning letter was issued to McNeil at a Puerto Rico plant, after a recall was issued for several OTC drugs, including Tylenol, Motrin, and Benadryl, for a musty odor. That recall was expanded less than 2 weeks ago. It was later found the musty odor was attributed to packing materials that had been stored on a pallet that had trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).
TBA is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. 2,4,6-tribromoanisole (TBA) is a common agent that causes moldy/musty odors in tainted packaged foods.
Since January, over 100 million bottles of J&J/McNeil over-the-counter drugs have been recalled – Tylenol PM, Tylenol Extra Strength, Children’s Tylenol, Benadryl Allergytabs, and more. This is the third recall of Tylenol products in less than a year due to poor manufacturing conditions and faulty production. More than 30 infant and children deaths have been reported, but have not been directly attributed to the recalled medication.