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FDA slams another Johnson & Johnson plant

By Annalyn Censky, staff reporter

NEW YORK (CNNMoney.com) -- Federal inspectors on Wednesday outlined alleged shortcomings at another Johnson & Johnson plant in Pennsylvania, after recently inspecting the facility which failed to receive a clean bill of health.

After a recent inspection, the Food and Drug Administration took issue with what it said was sloppy lab work and record keeping, product mix-ups and a failure to follow up on consumer complaints at the company's Lancaster plant, according a report released Wednesday, .

J&J was already under fire for allegedly poor conditions at a Fort Washington plant that makes children's pain and cold drugs, following massive recalls of over-the-counter medicines including Tylenol, Motrin and Benadryl.

But on Wednesday, the FDA cited 12 additional problems at the Lancaster facility operated by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture between J&J and drugmaker Merck.

J&J said it stands by its statement issued earlier this week that "JJ/MCP takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible."

The unit, which was formed to develop and market over-the-counter drugs derived from Merck's prescription medicines, makes non-prescription products such as heartburn relievers Mylanta and Pepcid and the multi-symptom relief drug Imodium.

FDA inspectors said J&J staff failed to follow up on several consumer complaints, including instances where consumers said they found mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets.

Federal regulators also said the factory didn't properly document equipment malfunctions or keep adequate maintenance records. Inspectors said they found unlabeled test tubes filled with product sitting out on a counter. The factory also didn't properly clean utensils used in the drugmaking process, the FDA said.

Shares of J&J (JNJ, Fortune 500) fell about 2.5% after the news Wednesday, and Merck (MRK, Fortune 500) fell 1.3%. To top of page

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Data as of Nov 24


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