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J&J Unit Warned of Problems in Sterilization Devices

By JENNIFER CORBETT DOOREN

http://online.wsj.com/article/SB10001424052748704026204575266782834194838.html

WASHINGTON—The Food and Drug Administration warned a Johnson & Johnson unit about failures to properly handle and correct problems reported with certain sterilization devices.

The March 12 warning letter was released Tuesday and relates to devices made by Advanced Sterilization Products, an Irvine, Calif., company that's part of Ethicon Inc., which is a unit of J&J. The letter stemmed from an FDA plant inspection that was conducted from June through September 2009.

The letter discussed several consumer complaints relating to the company's Sterrad and other devices, some of which included reports that the sterilizers emitted an oil mist. The problems were first reported in 2007.

The FDA said actions taken by the company were "inadequate" to correct and prevent recurrence of the events. Other reported problems included small cracks in devices that allowed customers to come in contact with hydrogen peroxide used in one type of device.

The FDA said Advanced Sterilization Products attempted to fix the reported problems by recalling and taking what's known in the industry as a field action to fix the problems. However, the FDA said an assessment wasn't conducted to see if the corrections were effective.

In a statement, ASP said it "has aggressively implemented a number of specific corrective actions to address deficiencies in some of our internal processes, and we continue to work with the agency to address and quickly resolve any outstanding issues." The company noted the letter didn't cite any product "performance, efficacy or safety issues."

In the letter, the FDA requested that a third party audit ASP's manufacturing plant to look at quality-assurance systems and report to the agency by Aug. 1, 2010. Follow-up reports are being requested each year through 2012.

The warning letter adds to problems faced by J&J, which is coping with a wide-ranging recall of liquid Tylenol and other children's products after manufacturing problems at its Fort Washington, Pa., plant. A top company executive is scheduled to testify Thursday before the House Committee on Oversight and Government Reform as part the panel's investigation into the recall, along with a top FDA official.

On Tuesday, the J&J unit that makes Tylenol outlined plans to address quality issues that stemmed from the recall. McNeil Consumer Healthcare said it is improving processes and employee training in the company's manufacturing and quality operations. The company said it has made "significant organizational changes" and, even before the most recent recall was announced, retained a third-party expert to assist in identifying corrective actions that it needs to take.

—John Kell contributed to this article.
Write to Jennifer Corbett Dooren at [e-mail]


http://online.wsj.com/article/SB10001424052748704026204575266782834194838.html