ThyssenKrupp Access Corp. – FDA Warning Letter, Mar 10, 2011

An FDA inspection of ThyssenKrupp Access Corp. in Grandview, Missouri, from February 24 to March 10, 2011, revealed significant violations. The Flow II and Levant Patient Stair Lift devices were found adulterated under section 501(f)(1)(B) for lacking approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications. They were also misbranded under section 502(o) for failing to submit a 510(k) premarket notification, as their design and technological characteristics differed significantly from cleared models. Additionally, the firm's manufacturing processes for several devices violated the Quality System (QS) regulation (21 CFR Part 820). Deficiencies included failures in complaint handling (21 CFR 820.198), establishing and documenting corrective and preventive actions (21 CFR 820.100), identifying and documenting training needs (21 CFR 820.25(b)), conducting quality audits (21 CFR 820.22), and management review of the quality system (21 CFR 820.20(c)). The devices were also misbranded under section 502(t)(2) due to Medical Device Reporting (MDR) failures (21 CFR Part 803). These included not reporting a device malfunction (stair lift fire) within 30 days (21 CFR 803.50(a)(2)) and failing to develop written MDR procedures (21 CFR 803.17). The firm's responses to the FDA 483 were deemed inadequate. ThyssenKrupp must promptly correct these violations within fifteen business days to avoid regulatory actions like seizure, injunction, civil money penalties, and impacts on federal contracts, PMA approvals, and Certificates to Foreign Governments.