483
Sunshine USA, LLCFDA 483 - Sunshine USA, LLC - August 17, 2023
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Record Details
An FDA inspection of Sunshine USA, LLC, a manufacturer of suntan beds in Kingsport, TN, revealed significant deficiencies in their quality management system. Observations included the absence of device master records, inadequate device history records, and failures in quality auditing, equipment calibration, training procedures, and complaint handling processes.
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ID · 0f253985-8276-453b-b0c5-99c447b8ebf8