J&J gets FDA warning about handling of complaints
NEW YORK—The Food and Drug Administration is warning a Johnson & Johnson unit that it failed to look into dozens of consumer complaints about its K-Y Liquibeads Vaginal Moisturizer and other products in the last two years.
The FDA sent a warning letter to the company's McNeil division on May 22. It said the company received 227 complaints about the K-Y Liquibeads between June 2010 and December 2011, and more than 100 complaints were either not thoroughly evaluated and investigated, were closed without written justification, or were incorrectly closed because the company believed the complaints referred to invalid production lot numbers.
Product issues have dogged the health care giant in recent years. The New Brunswick, N.J., company has issued about 30 product recalls since September 2009, most of them from the McNeil Consumer Healthcare unit. The recalls affected everything from children's and adult Tylenol to defective hip implants and prescription drugs for HIV and seizures.
The letter said McNeil also did not inform the FDA in a timely manner after it found out that one consumer had lost a tooth while flossing with Reach, and after a case of Toxic Shock Syndrome was confirmed in a woman who had used O.B. Tampons. Companies are required to tell the FDA about injuries or serious side effects within 30 days.
The FDA also said the company did not perform adequate testing of the compatibility of K-Y Liquibeads with latex condoms and did not properly evaluate the shelf life and storage requirements of the Liquibeads.
The latest FDA letter is based on inspections conducted in December and January.
Shares of Johnson & Johnson slipped 33 cents to $62.26 in midday trading.