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

Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 17,156.85 24.88 0.15%
Nasdaq 4,562.19 9.43 0.21%
S&P 500 2,001.57 2.59 0.13%
Treasuries 2.60 0.01 0.42%
Data as of 7:43pm ET
Company Price Change % Change
Bank of America Corp... 16.77 0.06 0.36%
Apple Inc 101.58 0.72 0.71%
Yahoo! Inc 42.59 -0.12 -0.28%
Microsoft Corp 46.52 -0.24 -0.51%
Alcoa Inc 16.28 0.12 0.74%
Data as of 4:03pm ET

Sections

Profit was nearly cut in half for Pier 1 Imports during the most recent quarter. More

The Federal Reserve is probably not going to raise interest rates until the summer of 2015 at the earliest. More

Apple's new HealthKit platform, set for release in conjunction with the new iOS8, has been delayed by a bug. More

Frederick Hutson launched Pigeon.ly in 2012 to help inmates communicate with their friends and family. He's on target for $1 million in sales this year. More

Occupy Wall Street offshoot Strike Debt says it has abolished nearly $4 million in private student loan debt for students who attended Everest College, part of Corinthian Colleges. More

Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.