483
BURTON MEDICALBURTON MEDICAL – FDA 483, Feb 20, 2026
Record Details
BURTON MEDICAL in Addison, IL, underwent an FDA inspection from February 17-20, 2026, which identified one significant observation. The firm failed to register its APEX LED Class II medical device with the Global Unique Device Identification Database. This indicates a compliance issue regarding medical device identification requirements.
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- Chicago District Office
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ID · 74e28dd2-016a-4846-972c-73f15518c086
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