A unit of Johnson & Johnson ($JNJ) is facing some tough FDA scrutiny over how it manufactures device products ranging from sexual lubricants and tampons, to feminine napkins and dental floss.
Regulators warned the company's McNeil-PPC division in a May 22 letter that cited various quality system and reporting violations regarding how the products were manufactured, packaged or stored. The FDA based its letter inspection of the company's Skillman, NJ facility from Dec. 12, 2011 through Jan. 19, 2012. Among the products cited: KY Liquibeads, Warming Liquid and Sensual Silk Ultra Gel, O.B. Tampons, Stayfree and Carefree Menstrual Napkins and Reach floss.
FDA regulators detailed a number of citations. The company didn't conduct a long-term stability study to determine shelf life and storage requirements for K-Y Liquibeads and it was also cited for saying the product was compatible with latex condoms even though it didn't test the assertion using all of the ingredients found in the product. Also at issue is that the company closed consumer complaints regarding the product ("does not dissolve" and "uncharacteristic consistency/texture") without any written explanation, contrary to its own policies, regulators said.
Regulators also criticized the company for not reporting that a person lost a tooth while using the company's Reach dental floss within the 30-day timeframe the regulation requires. Additionally, the FDA cited the J&J unit for a similar issue over how it reported a patient's diagnosis of toxic shock syndrome after using one of the company's O.B. Tampons.
McNeil-PPC is supposed to respond to the letter within 15 days and outline steps it has taken on how to correct the violations and prevent future ones, and the timeframe that will be necessary to get the job done.
Back in early 2011, the FDA finalized the terms of a consent decree against the J&J unit and two of its officers, for not complying with good manufacturing practice requirements. The company's various facilities also dealt with extensive recalls in 2010, regarding production of drugs such as children's Tylenol, Motrin, Zyrtec and Benadryl.
- read the FDA's warning letter
- check out MedCity News' take
- here's Pharmalot's coverage