If the shuttering of a Tylenol plant gave Johnson & Johnson a headache, this most recent investigation into a factory that makes Pepcid, Immodium and Mylanta is surely giving the company a case of sour stomach (get it? Medicine jokes!).The Lancaster, Pa. plant was issued a Form 483 by the FDA earlier this month, and now a new report indicates 12 violations of good manufacturing processes.
Johnson & Johnson-Merck Consumer Pharmaceuticals owns the plant and it is operated by the company’s McNeil division. McNeil was recently in the news for having to shut down its Fort Washington plant after recalls of Motrin and Tylenol were linked to 20 manufacturing violations there.
The newest report, released on Wednesday, lists the 12 violations, five of which were also seen at the now-closed Fort Washington plant. Problems at the plant included: Equipment not properly documented or without adequate maintenance records; unlabeled test tubes with product sitting on the counter; and improperly cleaned utensils used in the drug making process.
This pattern of events is so similar to the Fort Washington plants could mean a bigger problem for plants across the country — and the consumers who take over-the-counter medications every day.
“If this is going on in Johnson & Johnson plants that make over-the-counter drugs, is this indicative of what is going on in other parts of the company’s business?” David Rosen, who worked at the FDA for 14 years, tells CNN.
Pepcid factory problems mirror Tylenol mess [CNNMoney]