FDA: Tylenol Factory Conditions Unacceptable
Johnson & Johnson is under fire after a recent FDA report highlighted multiple serious concerns about the conditions at one of their drug factories.
The 17-page report released by the FDA slammed the conditions at a Johnson & Johnson factory that produced Tylenol, Motrin, Benadryl and more over-the-counter drugs. The inspection noted serious lapses in security and quality control. The FDA is currently considering action, including the possibility of filing criminal charges.
Johnson & Johnson has suspended production at the Pennsylvania plant.
The FDA report, listed several problematic observations at the Johnson & Johnson McNeil PPC drug manufacturing division. Among the most troublesome:
The responsibilities and procedures applicable to the quality control unit are not fully followed.
There are no written procedures for production and process controls designed to assure (sic) that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure (sic) that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.
"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."
Despite the recall, the FDA says that the potential dangers from the recalled drugs are remote.
However, as Parija Kavilanz of CNNMoney reports, 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 specifics of the product recall are listed at the McNeil website.
- Children's Tylenol recall: FDA slams factory conditions (CNNMoney)
- Full FDA Report (PDF)
- Recall Information (McNeil)
- Drugs and Medical Device Recalls (FindLaw)
- Defective and Dangerous Products - Get Help Now (FindLaw)
- Products Liability Info Ctr (provided by Kahn, Gordon, Timko & Rodriques, P.C.)
- Products Liability FAQ (provided by Shamberg, Johnson & Bergman)