Children's Tylenol recall: FDA slams factory conditions
NEW YORK (CNNMoney.com) -- A scathing report released Tuesday by the Food and Drug Administration slammed conditions at the factory that produced the children's Tylenol, Motrin, Benadryl and other over-the-counter drugs that were recalled over the weekend.
The 17-page FDA inspection report conducted in late April detailed quality and security lapses at the Fort Washington, PA-based facility, which is owned by Johnson & Johnson's (JNJ, Fortune 500) McNeil PPC drug manufacturing division. The agency said it is considering a wide range of actions including possible criminal penalties.
Johnson & Johnson said it has temporarily suspended production at the plant. It is the company's only plant that manufactures all of its liquid pediatric drugs.
"We have no higher concern than providing parents with the highest quality products for their children," the company said in a statement Tuesday. "The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us."
While the FDA said parents should immediately discontinue use of any of the recalled products, the agency maintained that the potential for adverse medical effect from the recalled drugs is still "remote."
In a press call Tuesday, FDA Commissioner Margaret Hamburg said parents should immediately use generic versions of the recalled drugs.
Numerous problems at the plant
Deborah Autor, FDA's director with the Office of Compliance, said the agency met with Johnson & Johnson's senior management in February.
"We expressed serious concerns about McNeil's manufacturing operations," she said. Although the FDA was scheduled to do a routine inspection of the plant, she said the February meeting "drove us to inspect the plant more quickly."
Autor also admonished McNeil for its latest recall, its fourth in the past seven months.
"This is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so," she said.
The FDA will now conduct a more detailed analysis of its findings before determining what the consequences could be for McNeil. She said the FDA's actions could range from a warning letter to criminal penalties.
In its report, the FDA said McNeil did not initiate "corrective and prevention action" after it had received 46 consumer complaints from June 2009 to April 2010 regarding foreign materials and black or dark specks in its drugs.
The agency cited the facility for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of components and drug products.
Autor said the agency's findings showed that McNeil bought contaminated raw material from its vendors, which tested positive for a type of bacteria that the the FDA has not yet identified.
However, the agency said McNeil's testing showed that the contamination did not reach its finished products, it is conducting its own probe.
The FDA found there were no written procedures to ensure "the identity, strength, quality, and purity" that the drugs produced there were said to possess.
Further, the agency said the plant's employees "[were] not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations."
McNeil recalled some 50 children's versions of the non-prescription drugs on Saturday for quality concerns, including "tiny particles" in some of the products that the company said may be solidified product ingredients or manufacturing residue such as tiny metal parts.
The FDA said the recall affects some 1,500 "lots" of the drugs which were distributed both in the United States and internationally.
Logo of the FDA.The US Food and Drug Administration released a report today harshly criticizing the conditions at a  factory that produced medications recalled this weekend.

The report, the result of an FDA inspection conducted at the facility, said that the plant in question, located in , Pennsylvania, had upwards of 20 documented manufacturing problems, including both quality and security issues.

According to the report, material used in the medicines produced were contaminated with a type of bacteria not yet identified, and the factory had not had sufficient quality control procedures or facilities for testing the quality of products.  The report also noted that employees had received insufficient training in safe manufacturing procedures.

The FDA's inspection of the plant had begun in mid April, and concluded last Friday. A recall of the drugs, which included , ,  and , was issued by Johnson & Johnson later on Friday. The products affected were sold in twelve countries worldwide, including the US.

According to , a division of J&J, the recalled medications can include higher than indicated amounts of active ingredients, foreign particles, or ingredients that don't meet requirements for testing. The recalls followed at least 46 consumer complaints in the last year of "black or dark specks" found in J&J Tylenol products.

According to a senior FDA official, "this is yet another example of when a company has to take full accountability for the quality of its drugs with severe consequences for not doing so."

In a response, J&J said in a statement that "we have no higher concern than providing parents with the highest quality products for their children" and "the quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us." The company said the plant affected has temporarily ceased all production.