Our Terms of Service and Privacy Policy have changed.

By continuing to use this site, you are agreeing to the new Privacy Policy and Terms of Service.

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

Index Last Change % Change
Dow 21,674.51 -76.22 -0.35%
Nasdaq 6,216.53 -5.39 -0.09%
S&P 500 2,425.55 -4.46 -0.18%
Treasuries 2.19 -0.00 -0.23%
Data as of 7:13pm ET
Company Price Change % Change
Bank of America Corp... 23.62 -0.02 -0.08%
Ford Motor Co 10.56 -0.08 -0.75%
Advanced Micro Devic... 12.37 0.03 0.24%
Foot Locker Inc 34.38 -13.32 -27.92%
Chesapeake Energy Co... 3.96 0.08 2.06%
Data as of Aug 18
Sponsors

Sections

Not only do many women depend on insurance coverage for maternity care and contraception, it commonly falls to them to plan health care and coverage for the whole family. Yet as leaders in Washington discuss the future of American health care, women have not always been allowed in the room. More

Despite having more financial "skin in the game" than ever, many consumers don't make any attempt to compare prices for health care services, a newly released study found. More