The Food and Drug Administration isn't satisfied with all of Advanced Sterilization Products' efforts to resolve manufacturing and quality assurance issues, the agency warned in a letter sent to the Sterrad manufacturer last month.
The warning letter follows a routine 2009 inspection of the Ethicon subsidiary's Irvine, Calif., plant that uncovered lapses in its responses to product defects, as well as ASP's reply to the inspection's findings.
Among the violations that the FDA's letter says ASP has not adequately addressed are its failure to sufficiently follow up on certain customer-reported equipment flaws and ensure that those flaws have been corrected and prevented from recurring. Those reported flaws included Sterrad model 50 and 100S gas plasma sterilizers that produced an oily mist, CycleSure biological indicators that cracked and leaked hydrogen peroxide, and biological indicator instructions that were not thorough in their descriptions.
The FDA is requiring the company to hire an external consultant to audit its manufacturing and quality assurance processes, report the results by Aug. 1, and conduct follow-up audits in 2011 and 2012, or else face regulatory sanctions.
In a statement, the manufacturer says that it has implemented corrective actions and is working with the FDA to resolve its remaining concerns. It also points out that the warning letter did not include a product recall, cite safety deficiencies or prohibit the company from manufacturing and distributing its equipment. "Customers can remain confident that ASP products are safe and effective when used as directed," says ASP.
David Bernard
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