FDA reports slew of problems at and plant

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FDA reports slew of problems at & plant

By Lyndsey Layton Washington Post Staff Writer

Thursday, July 22, 2010; 9:54 PM

Federal officials who inspected a & 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 & 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 &

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.

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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. "

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.

The FDA inspection took place about a month after a top &

executive testified on Capitol Hill that the company was working feverishly to

address all shortcomings and restore consumer confidence.

In January, the FDA identified problems at a & 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.

It became the first of four recalls of & 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 &

facility in Fort Washington, Pa., the only plant where they were being

made.

The company has temporarily shuttered the Fort Washington plant while it fixes

flaws there. In a call with investors Tuesday, & 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 & about $600 million in lost sales this year. The affected

products will not be back on store shelves until next year.

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

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