Israeli Company Working to Resolve Import Ban

It certainly didn’t take executives at Oridion Systems Ltd. long to resolve part of an import ban on the company’s products. Barely one month after the U.S. Food and Drug Administration (FDA) barred Oridion from importing any of its devices into the United States, the Israeli firm had narrowed the ban to just one product line.

The FDA banned Oridion’s products in December after the company failed to fix various violations at its Jerusalem manufacturing plant. U.S. regulatory officials imposed the ban nearly six months after first warning the firm about its specific failures; the initial warning resulted from an investigation first triggered by Philips Healthcare’s recall of eight lots of infant and neonatal carbon dioxide sampling lines. Philips feared the lines contained hair-like plastic strands that possibly could be inhaled by infants.

In October, the FDA sent a warning letter to Oridion outlining its concerns about the plastic strands and other safety issues. In addition to finding the company’s MicroStreamCO₂ Filterline “adulterated,” FDA inspectors claimed that Oridion’s contract manufacturer did not follow specified quality requirements, and the company itself did not maintain proper device history records. The inspection also found inadequate quality controls in place as well as no documentation for the handling of non-conforming products.

“Given the serious nature of the violation of the Act, the MicroStreamCO₂ Filterline manufactured by your firm is subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C 381 (a), in that it appears to be adulterated,” the FDA’s Oct. 4 warning letter stated. “As a result, the FDA may take steps to refuse these products, known as ‘detention without physical examination,’ until these violations are corrected…Your firm should investigate and determine the cause of the violations and take prompt actions to correct the violations and bring the products into compliance.”

By mid-January, Oridion had corrected most of the violations that had prevented its products from being shipped to the United States. In a Jan. 19 news release posted on its website, the company announced that the import ban on its medical devices had significantly been narrowed to include only infant neonatal intubated CO₂ sampling lines. “While the infant neonatal CO₂ sampling lines remain on import alert and will not be commercially available in the United States until further notice, the company has immediately resumed shipments of all other products including CO₂ sampling lines, modules and patient monitors,” the news release read.

Oridion’s products are based on its Microstream technology, which measures the carbon dioxide in a patient’s breath. The Jerusalem-based company—which also operates an office in Needham, Mass.—reported a 19 percent increase in 2011 revenue to $64.5 million. Operating income rose 10.4 percent to $6.7 million, according to preliminary unaudited financial results.