Oridion Systems Ltd. (SWF:ORIDN) is in the FDA spotlight for violations at its Jerusalem, Israel, manufacturing facility.
Cited violations related primarily to missing device history documentation and insufficient quality controls related to nonconforming products.
The investigation was launched after Philips (NYSE:PHG) recalled eight lots of infant and neonatal carbon dioxide sampling lines manufactured by Oridion on concerns that they may contain hair-like plastic strands that infant patients could inhale.
Left uncorrected, the sampling lines may be subject to FDA refusal and "detention without physical examination," according to the warning letter.
Oridion took immediate steps to rectify the issues cited by the watchdog agency.
"At the conclusion of the FDA inspection, the company assembled a team, including its internal quality and regulatory associates as well as outside experts, to initiate and implement corrective actions," according to a company press release. "A formal response will be submitted to the FDA as is required under the letter."