Advanced Sterilization Products, a division of the Johnson & Johnson-owned devicemaker Ethicon, has failed to adequately address problems with several of its products, according to a Food and Drug Administration warning letter.
FDA warns maker of sterilization products
The letter, sent March 12 and made public this week, said a 2009 inspection of the company's Irvine, Calif.-based plant revealed that the manufacturer has not properly addressed specific problems with it Sterrad-brand medical-equipment sterilizers and biological indicator, its Cidex-brand disinfectants and test strips, and its Evotech-brand endoscope cleaners and reprocessors.
According to the letter, steps taken by the company to address customer complaints about products—which included sterilizers that emitted an oil mist and biological indicators that leaked hydrogen peroxide—were not sufficient to prevent recurrence.
The FDA has required Advanced Sterilization to take several actions to correct the violations or face potential regulatory action. The company must undergo a third-party audit of its manufacturing facility and submit those finding to the FDA by Aug. 1. It must also submit annual follow-up reports through 2012 showing that the problems have been properly addressed.
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