The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

IsoLux Slammed With Warning Letter for Procedural Failures

April 8, 2016

IsoLux has earned a warning letter from the FDA for several procedural failures related to its A/C-powered illuminators.

The Jan. 8 warning letter follows an inspection of the company’s manufacturing facility in Naples, Fla., from Nov. 4‒6, 2015.

In the warning letter, the FDA says IsoLux failed to keep documents related to an investigation for uniformity and homogeneity of its fiber optic cable illumination and misalignment of its Isovu Headlight Camera System in March 2011. The company also failed to implement conformity procedures to adequately qualify the new supplier of fiber optic cables in 2011.

Both failures are continued observations from previous inspections in January 2010 and August 2005, the FDA says.

In addition, the warning letter hits IsoLux for failing to ensure that incoming products meet specifications, failing to maintain design change procedures and failing to establish a design history file for 1180 XSB Xenon Light Source devices.

IsoLux sent a letter to the FDA on Dec. 1, 2015, regarding observations in a Form 483, but the agency says the response did not provide adequate supporting evidence that the company had implemented corrections and planned actions.

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