483
Arch Medical Solutions - Escondido LLCArch Medical Solutions - Escondido LLC – FDA 483, Apr 7, 2023
Record Details
Arch Medical Solutions - Escondido LLC, a Class II medical device contract manufacturer, was inspected by the FDA. The inspection revealed a significant issue with the firm's complaint handling process, specifically the failure to properly evaluate and investigate complaints involving device, labeling, and packaging specifications. This indicates a serious lapse in quality system procedures.
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ID · ec961fb3-34b9-4747-813c-5616d0946bb7
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