483
United Dental Resources CorporationUnited Dental Resources Corporation – FDA 483, Aug 7, 2026
Record Details
An FDA inspection of United Dental Resources Corporation (dba AmericaSmiles) in University Park, IL, revealed three significant observations related to medical device manufacturing. The firm was cited for failing to include unique device identifiers on product labels, inadequate complaint investigation records, and a lack of maintained risk management activities for its GenesisZr dental products. These issues indicate deficiencies in quality system compliance for medical device production.
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ID · e5c98857-03ed-4a09-8fbb-f18beafd7f69
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