FDA reports slew of problems at Johnson & Johnson plant

[mike r]

Source: Washington Post

Federal officials who inspected a Johnson & Johnson manufacturing plant that makes Mylanta, Pepcid and other popular heartburn medicines unearthed quality control problems, chaotic recordkeeping and complaints by consumers that medicines were either ineffective or contained pills from different products in the same retail package. The facility in Lancaster, Pa., is the third Johnson & Johnson plant to be flagged this year by the Food and Drug Administration for serious manufacturing defects -- an unusual number for a single company.

The FDA's latest report was released Wednesday, a day after Johnson & Johnson told investors it had received a subpoena from a grand jury in eastern Pennsylvania. The company is also the subject of a congressional probe into recalls this year of more than 100 million bottles of adult and children's Tylenol, Motrin, Benadryl, Zyrtec and other popular over-the-counter medicines. The company has not recalled any products made in the Lancaster facility, which is a joint venture with Merck...

FDA officials who inspected the Lancaster facility from June 22 to July 9 documented 12 deficiencies, including the failure of the company to investigate why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles. Experts say that kind of error suggests both a lapse in the manufacturing process as well as weak quality controls. Inspectors described with frustration having to repeatedly ask for documents and waiting days to receive what should have been readily available, including things as basic as an organizational chart.

Federal inspectors found that the Lancaster plant could not ensure that drugs produced there were up to standard. "Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity," the inspectors wrote. They also said the plant failed to follow its own written procedures for cleaning and maintaining equipment...


Read more: http://www.washingtonpost.com/wp-dyn/content/article/2010/07/22/AR2010072206169.html

[KT2000]

1. they must have been turning in

excellent monthly profits and keeping headquarters happy.

[dencol]

2. SHUT THEM DOWN

They are endangering public safety for profits, and are rotten to the core. Their corporate charter should be pulled.

[MannyGoldstein]

5. J&J won't be shut down, but heads will roll

The FDA takes these things very seriously - for example, from the article, here's what happened to another plant that screwed up:

The company has temporarily shuttered the Fort Washington plant while it fixes flaws there. In a call with investors Tuesday, Johnson & Johnson executives said that they don't expect to reopen that plant until mid-2011 and that the company is laying off 300 of the 400 workers based there. The shutdown is expected to cost Johnson & Johnson about $600 million in lost sales this year. The affected products will not be back on store shelves until next year.

It's awful that average workers will be laid off, but the managers and execs who fucked up will likely lose their jobs too.

[pipoman]

7. There ya go

send them bastards to manufacturing in other, less restrictive, countries and fuck them employees...McDonalds is hiring..

[dencol]

8. As if another Company wouldn't swoop in.

Plus, we need to adjust trade policies so that does not happen. I get your point though. I guess mine is that if the government would take bold action against a company (like BP, for example) who egregiously harms the public, others will shape up real fast. Nationalize a bank that abuses customers or the economy, and the others will clean up their act; nationalize the oil companies, and power companies will take notice. There are many things that can improve if the government actually demonstrates a backbone and interest for the public good.

[Ian David]

3. Really, shouldn't we let the Free Market decide what pills go inside which bottles?

:sarcasm:

[jmowreader]

6. I think they should...

Just think...if one box labeled "Tylenol, 100 Count" contained:

42 Tylenols
30 birth control pills
21 Aleves
3 Oxycontins
and 2 Viagras

but another box of Tylenol contained 95 Tylenols and five Ecstasy pills...

imagine the sales increase! Man, you'd be able to cure your headache and have fun all at the same time!

The problem is, in every ninth box you'd get 100 Syrup of Ipecac softgels.

[Blandocyte]

4. Keep big government out of my bottle of pills

containing various products of varying dosages and purity! :sarcasm:

Embarrassing that this happened at a U.S. plant. This is the sort of story used to scare us off "Canadian pharmaceuticals" and foods/medicines made in China.