FDA flags Guidewire on sterilization issues

March 10, 2010 by MassDevice staff

Salem, N.H.-based Guidewire Technologies earns a warning letter from the Food & Drug Administration for quality system violations at a manufacturing plant.

Guidewire logo

The Food & Drug Administration warned a Salem, N.H.-based maker of guidewires used in catheters that its quality systems aren't up to snuff.

Regulators made public March 10 a warning letter sent to Guidewire Technologies Inc., advising the company that they are in violation of three quality systems regulations that must be remedied.

The agency said in a Feb. 26 letter that the company is failing to test each production run to ensure the products have been sterilized and that the company's Teflon guidewire coating process has not been validated. In addition, the agency said internal quality systems haven't been audited since 2006.

Douglas Curtis, the president of Guidewire Technologies, declined to comment on the letter to MassDevice, offering only that "we'll be responding to the FDA."

FDA officials have been much more aggressive in the past six months in flagging quality systems problems, as part of a renewed emphasis on public health.

Guidewire Technologies was given 15 days to correct the problem before the public notice was released.

The warning notice was sent from the FDA's New England district headquarters in Stoneham, Mass.