FDA report criticizes conditions in factory that produced recalled medications
Wednesday, May 5, 2010
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, "[t]his 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.
- "Children's Tylenol recall: FDA slams factory conditions" — , May 4, 2010
- "FDA found bacteria in lots for recalled Tylenol" — , May 4, 2010