J&J unit feels FDA heat over handling of KY jelly product complaintsFrom MedCityNews

by Admin on May 29, 2012 · 0 comments

in News

warningA Johnson & Johnson (NYSE: JNJ) division for the company’s tampon, lubricant and dental floss business has drawn heat from the U.S. Food and Drug Administration over its handling of medical complaints and failing to comply with good manufacturing practices.

According to the warning letter issued May 22, McNeil-PPC adulterated its KY jelly and other KY products, Visine for Contacts; O.B. Tampons; Reach Floss; and Stayfree and Carefree Menstrual Napkins.

The letter also said the Skillman, New Jersey company failed to establish and maintain adequate procedures for validating the device design of those products.

It failed to adequately evaluate and investigate 68 medical complaints it received over its K-Y Liquibeads Vaginal Moisturizer over an 18-month period from June 2010 to December 2011.

The FDA also pointed out that the company violated its own procedures by failing to provide any written justification for complaints over its KY moisturizer like “Does Not Dissolve” and “Uncharacteristic Consistency/Texture.”

The company also came in for criticism for for filing reports late, 30 days past the due date in two cases referenced in the letter. One case involved reporting a toxic shock death following the use of its o.b. tampons. Another case involved a lost tooth following the use of its dental floss.

The regulator said it could not determine the adequacy of the company’s responses until J&J completed an investigation of each one and provided them to the FDA.

The warning letter comes at a time when Johnson & Johnson is trying to to turn its consumer division around and is the first on the watch of its new CEO Alex Gorsky.

Last year, the company signed a consent decree with the FDA, requiring McNeil-PPC to take enhanced measures to addressing deficiencies with certain facilities it operates. To comply with the decree the division voluntarily shut down its Fort Washington, Pennsylvania facility in April 2010 and has kept it closed until its overhaul is complete, a third-party consultant certifies that its operations are in legal compliance, and the FDA agrees with the third-party certification, according to J&J’s annual report filed earlier this year.

via MedCity News http://medcitynews.com/2012/05/jj-unit-feels-fda-heat-over-handling-of-ky-product-complaints/?utm_source=rss&utm_medium=rss&utm_campaign=jj-unit-feels-fda-heat-over-handling-of-ky-product-complaints

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