Tylenol plant: From bad to worse

NEW YORK (CNNMoney.com) -- Government safety inspectors pushed for a recall of popular children's medicines at least three months before a Johnson & Johnson drugmaking unit removed the products from store shelves, according to documents obtained by CNNMoney.

In fact, Food and Drug Administration inspection reports going back to 2003 chronicle a build up of problems at the now-shuttered plant in Fort Washington, Pa., at the center of the widespread recall of Tylenol, Motrin, Benadryl and other over-the-counter drugs.

The FDA raised the recall issue this year after conducting an inspection of the Fort Washington facility from Jan 28 to Feb. 2. Inspectors questioned whether Johnson & Johnson's McNeil unit had adequately tested a batch of raw materials that was used to make infant's and children's liquid Motrin in 2009.

McNeil told the FDA that it was satisfied with its own testing. It proceeded to make the Motrin drugs, and chose not to undertake additional testing of finished Motrin products.

But the lead FDA inspector was not satisfied and determined that "the potential for contamination of the entire lot remains a possibility."

"The most appropriate corrective action would have been to get control of all finished product," the FDA said in the inspection report. "Leaving potentially affected [Motrin] lots on the market did not appear to be in the best interest of infants and children who are the intended consumer."

The FDA generally can recommend a recall, but does not have the authority to force one unless the product poses potential for serious injury or death.

On April 30, McNeil recalled 1,500 lots, or about 135 million bottles, of children's and infant's Motrin, Tylenol, Benadryl and Zyrtec drugs, saying that some of these products did not meet "quality standards." It noted the presence in the drugs of tiny metal particles and for the potential of bacterial contamination.

McNeil shut the Fort Washington plant on May 6, the same day that the FDA issued a scathing inspection report slamming conditions at the facility.

McNeil, which has issued five recalls of its cold and pain relief products over the past eight months, is currently being investigated both by the FDA and lawmakers.

At a congressional hearing last month, a senior FDA official spoke about the agency's "growing concerns about the quality of the company's manufacturing process."

"These concerns have led to a number of unsatisfactory inspections and consumer recalls," said Joshua Sharfstein, principal deputy commissioner at the FDA.

Sharfstein said that in recent the years the FDA identified several problems with manufacturing processes at facilities run by McNeil, including laboratory controls, equipment cleaning processes and a failure to investigate identified problems.

Some previous FDA inspection reports of the Fort Washington facility obtained by CNNMoney chronicle such problems -- including repeat offenses.

The FDA typically conducts an inspection of a drug manufacturing facility once every two years, but the agency can increase the frequency.

In McNeil's case, safety inspections were on a routine cycle until 2008, after which the FDA stepped up its oversight of the Fort Washington plant.

An inspection report from December 2003 noted a mislabeling problem related to some lots of children's soft-chew Tylenol. The report said the packages of the product listed an incorrect amount of an ingredient per tablet. McNeil did not recall the affected products but destroyed and relabeled the products that had not yet been released into the market.

In January 2006, FDA inspectors noted that some equipment used to make drugs had not been properly cleaned.

Another report from February 2008 listed what appear to be more serious problems, such as insufficient follow-up and investigation of consumer complaints.

In May 2009, inspectors once again highlighted deficiencies including incomplete investigations into contamination of raw materials. More broadly, the report said that laboratory controls at the Fort Washington plant "do not include the establishment of scientifically sound and appropriate sampling plans to ensure that components conform to appropriate standards of identity, strength, quality and purity."

Additionally, the report said that procedures describing oral and written complaints against drug products made at the plant were not being followed.

Both of these issues are serious violations, according to drug manufacturing experts.

"It seems that from 2006 and 2009, quality and safety issues worsened at the plant," said one expert who did not want to be named. "It looks like there was a change in the quality assurance management at this facility during that time. Something as little as that can have a big impact on the entire operation."

McNeil declined to comment for this article.

Since it temporarily shut production at the plant last month, the company said that it is taking steps to bring its operation "back to a level of quality that Johnson & Johnson demands of its companies."

McNeil also said the company has made significant organizational changes but did not provide details about the changes.