Wes Bucey
Prophet of Profit
As I browsed the news reports today, I came across this recent item relating to a major corporation being caught en flagrante delicto by FDA inspectors. Is this a harbinger of a trend? (Note this is the USA, not some third world country barely out of the Stone Age.)
THE QUESTION:
In YOUR opinion, is this an isolated corporation or are there many other bad eggs lurking which just haven't been caught? Got an underlying reason/justification for either opinion?
THE QUESTION:
In YOUR opinion, is this an isolated corporation or are there many other bad eggs lurking which just haven't been caught? Got an underlying reason/justification for either opinion?
Is this the same old story of the managers getting off scot free while the workers get hit in the paycheck?[FONT=Verdana, sans-serif]FDA reports slew of problems at Johnson & Johnson plant[/FONT]
[FONT=Verdana, sans-serif]By Lyndsey Layton[/FONT]
[FONT=Verdana, sans-serif]Washington Post Staff Writer
Thursday, July 22, 2010; 9:54 PM [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]The company has not recalled any products made in the Lancaster facility, which is a joint venture with Merck. [/FONT]
[FONT=Verdana, sans-serif]Spokesman Marc Boston said the joint venture "takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible." [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]
[FONT=Verdana, sans-serif]They also said the plant failed to follow its own written procedures for cleaning and maintaining equipment. [/FONT]
[FONT=Verdana, sans-serif]The FDA inspection took place about a month after a top Johnson & Johnson executive testified on Capitol Hill that the company was working feverishly to address all shortcomings and restore consumer confidence. [/FONT]
[FONT=Verdana, sans-serif]In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chemical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gastrointestinal problems. [/FONT]
[FONT=Verdana, sans-serif]It became the first of four recalls of Johnson & Johnson products in the past year, including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec. Those products were recalled after FDA inspectors found widespread manufacturing problems at the Johnson & Johnson facility in Fort Washington, Pa., the only plant where they were being made. [/FONT]
[FONT=Verdana, sans-serif]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. [/FONT]