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www.fdanews.com/articles/170308-treymed-warned-for-modifying-inspection-data-on-airway-adapters

TreyMed Warned for Modifying Inspection Data on Airway Adapters

March 11, 2015

TreyMed, a contract manufacturer of sensors, received a warning letter from the FDA after modifying entries in its inspection data record for parts that resulted in failures.

The Sussex, Wis., company tested numerous adult airway adapters in February 2014. According to the Jan. 9 letter, the testing “appears to have resulted in failures as the initial entry indicates” certain parts were rejected.  The letter was posted online Jan. 27.

However, in March, the entries lacked a determination of whether an investigation was required. The NMRs also did not state the disposition authority of the nonconforming material.

One indicates rework for adult airway adapters that were rejected, but there was no documentation of the rework instructions and no evidence to support the rework for the nonconforming airway adapters, the letter says. The final disposition status was unknown.

Other citations pointed to lapses in compliance with device history record procedures and corrective and preventive action procedures.

The company did not respond to a request for comment by press time. The warning letter is available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm430900.htm.