Raw materials used to make over-the-counter infant's and children's medications, which are subject to a massive recall, tested positive for bacterial contamination, according to a Food and Drug Administration inspection report released late Tuesday.The report, which also found more than a dozen other violations at the facility used to make the products, detailed a series of sloppy manufacturing processes including failure to maintain equipment, properly train employees and correctly weigh ingredients.
The report also indicates that the drug maker, Johnson & Johnson's McNeil Consumer Healthcare subsidiary, failed to investigate "46 consumer complaints regarding foreign materials, dark or black specks," some dating to June 2009.Receive breaking news alerts on your mobile device. Register »
McNeil announced a recall of more than 50 variations of infant's and children's Tylenol, Motrin, Zyrtec and Benadryl on Friday.
FDA officials said they were not aware of any reports of illness connected to use of the recalled products, and they described the chances of harm as remote in a press teleconference call late Tuesday.
But Commissioner Margaret Hamburg nonetheless repeated terse advice for parents: "Please discontinue using any of the name-brand products being recalled."Hamburg said all of McNeil's recalled products are available in generic form.The report documents "numerous deficiencies," including "a failure to sufficiently investigate problems in its manufacturing and in its drugs," failure to maintain proper testing facilities, and making changes in manufacturing processes without assuring that they would not harm consumers, said Deborah M. Autor, director of compliance in FDA's Center for Drug Evaluation and Research.
McNeil, vowing to remedy its operations, apologized "to those who rely on our medicines for the concern and inconvenience this recall may have caused."
"The quality issues that the FDA has observed … are unacceptable to us," the company said.
McNeil temporarily suspended production at the plant in Fort Washington, Pa., saying "we will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there."
The FDA inspection, made April 19-30, followed months of discussion between the agency and McNeil about the company's manufacturing methods.
No decision has been made about what further action, if any, the FDA will take, officials said. Options range from sending a warning letter to seeking criminal penalties.
FDA officials said they didn't have enough information to disclose what kind of bacteria contaminated the raw material. McNeil testing of samples of finished medication did not find any positive results for the pathogens.
The inspection was triggered at least in part by a warning letter sent to a McNeil plant in Puerto Rico in January in connection with another recall involving medications tainted by a chemical found in wooden shipping pallets.A foul odor associated with the chemical temporarily sickened about 70 people.
In that letter, FDA cited ongoing concerns with the company's quality control.
In an indication of particular displeasure with McNeil, FDA also took the unusual step of publicly criticizing the company for waiting more than a year before notifying the agency and fixing the problem with the pallets.
The weekend recall was the ninth product recall for McNeil this year, according to FDA figures.
"They've had a number of recalls and some observers are starting to question the integrity of the supply chain. The trend we've seen is not positive," said industry analyst Les Funtleyder at Miller Tabak & Co.
"We want reassurance that they understand the problems and are taking steps to remedy them."smile
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