Wednesday, May 30, 2012

J&J fail - pass me a chair!

FDA: J&J subsidiary flopped in handling K-Y Liquibeads complaints

A Johnson & Johnson subsidiary didn’t provide enough controls for quality assurance on a product that’s billed to enhance intimacy for women, the Food and Drug Administration said Wednesday.

The FDA in a warning letter dated May 22 said McNeil PPC Inc. didn’t properly review complaints about its K-Y Liquibeads product. It also didn’t validate its design.

New Brunswick-based Johnson & Johnson is one of the state’s biggest employers with about 14,000 workers.

Its McNeil division, which makes consumer products, has been under scrutiny by the FDA. The company, for example, suspended production of over-the-counter drugs such as Tylenol at a plant in Fort Washington, Pa., until regulators could be sure that they were safe and effective.

In an interview in April with the Newark Star-Ledger, J&J’s new chief executive officer, Alex Gorsky, said his priorities included addressing the company’s operational problems and winning back consumers it lost after its drugs were recalled.

J&J in a statement Wednesday acknowledged receiving the warning letter and said: “We take the issues raised by the FDA seriously. We will respond fully to their concerns.”

The FDA in its warning letter said it inspected McNeil’s administrative office in Montgomery Township from Dec. 12, 2011 to Jan. 19, 2012 – before Gorsky took over – and found five violations of what’s considered good manufacturing practice.

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