FDA WARNING_LETTER - Lynn Medical Instrument Company - February 21, 2008

On February 6-21, 2008, an FDA inspection of Lynn Medical Instrument Company in Wixom, Michigan, identified that their Accusensor Carbocone ECG Electrodes are adulterated under section 501(h) of the Federal Food, Drug and Cosmetic Act. The firm, a specification developer for these devices, failed to conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. Failure to establish procedures for corrective and preventive actions (CAPA) (21 C.F.R. 820.100(a)). 2. Failure to maintain complete procedures for receiving, reviewing, and evaluating complaints, including timely processing, documenting oral complaints, and determining MDR reportability (21 C.F.R. 820.198(a)). No complaints were reported since November 2005. 3. Failure to establish procedures for preparing and submitting Medical Device Reports (MDR) (21 C.F.R. 803.17, 820.198(a)(3)). 4. Failure to establish procedures for acceptance activities of incoming product, specifically for the Accusensor Carbocone ECG electrode (21 C.F.R. 82