Another FDA warning for J&J's McNeil unit

The FDA has another bone to pick with Johnson & Johnson's ($JNJ) McNeil unit. In a warning letter, the agency scolded McNeil for falling short on quality control, this time in connection with complaints about O.B. Tampons and a K-Y vaginal moisturizing product.

According to the FDA, McNeil didn't properly report or investigate the complaints. Over 7 months, the company received 277 complaints about K-Y Liquibeads, including 68 medical complaints that weren't properly investigated (or detailed by FDA, as Bloomberg notes). The others included complaints that the product didn't dissolve, that it had an odd consistency and that it didn't perform as expected.

McNeil never got approval for changes made to the product, the agency said, nor did it set up proper procedures for checking its shelf life or validating its design. Among the unapproved changes, Bloomberg notes, were the use of a gel-based capsule, a new applicator and new labeling.

The warning letter also mentions problems with a tardy report about toxic-shock syndrome diagnosed in an O.B. users; a complaint about a lost tooth related to use of its Reach dental floss

"We take the issues raised by the FDA seriously," the company said in a statement (as quoted by Bloomberg). "We will respond fully to their concerns and take whatever steps are needed to resolve these issues."

McNeil has been under heightened FDA scrutiny since quality-control problems prompted a series of recalls in 2009, including a massive recall of children's drugs. Three of the company's plants now are operating under an FDA consent decree. The company is still struggling to get the recalled drugs back onto store shelves, a process complicated by the fact that its Fort Washington, PA, plant is still shut for fixes.

- get the FDA warning letter
- read the Reuters article
- see the Bloomberg story