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

Search for Jobs

Index Last Change % Change
Dow 19,251.78 35.54 0.18%
Nasdaq 5,333.00 0.00 0.00%
S&P 500 2,212.23 7.52 0.34%
Treasuries 2.40 0.01 0.38%
Data as of 5:36am ET
Company Price Change % Change
Bank of America Corp... 22.16 0.32 1.47%
Chesapeake Energy Co... 7.58 0.10 1.34%
Wells Fargo & Co 55.55 1.20 2.21%
Cisco Systems Inc 29.33 -0.20 -0.68%
Apple Inc 109.95 0.84 0.77%
Data as of Dec 6
Sponsors

Sections

SeaWorld Entertainment, which saw a sharp dip in attendance this year, will eliminate about 320 jobs, the company announced Tuesday. More

Donald Trump's spokesman says the president-elect sold all of his stocks in June. That was a month after Trump's last financial disclosure. Trump doesn't have to disclose again until May 2018. More

Like with GamerGate and revenge porn, the 'Pizzagate' theory gained traction -- and an audience -- online. More

At least 398 colleges have food pantries on campus to serve students. The hunger problem is beyond a few sad stories. More