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Talk to a SpecialistTalk to a SpecialistDeChoker LLC, a manufacturer of the Dechoker tracheobronchial suction device, was found to have adulterated medical devices that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted February 17-26, 2021 identified critical violations including failure to validate manufacturing processes with adequate assurance and establish approved procedures, as required by 21 CFR 820.75(a). The devices, classified as Class II medical devices subject to Design Controls, had been manufactured and distributed despite these quality system deficiencies.