FDA WARNING_LETTER - DeChoker LLC - February 26, 2021

The FDA issued a Warning Letter to Mr. Carver regarding their medical device operations at 4880 Van Gordon St., Suite 200, Wheat Ridge, CO 80033, following an inspection from February 17-26, 2021. The inspection determined the firm manufactures the "Dechoker" tracheobronchial suction device, classified under 21 CFR 868.6810 and subject to Design Controls (21 CFR 820.30). The device was found adulterated under section 501(h) of the Act, due to non-conformity with current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** Specifically, the (b)(4) processes used in manufacturing Dechoker devices since May 2019 were not validated. The firm's responses were inadequate, lacking systemic corrective actions, containment activities for distributed products, and effectiveness measures until validation is complete. 2. **Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)):** * **Inadequate design inputs (21 CFR 820.30(c)):** Conflicting suction specifications, lack