FDA WARNING_LETTER - Craftmatic Industries, Inc. - August 08, 2014

The FDA issued a Warning Letter to Craftmatic Industries, Inc. after a June-August 2014 inspection. As a specification developer of the Craftmatic Adjustable Home-Use Therapeutic Bed, the firm's device was found adulterated under Section 501(h) for non-compliance with Quality System (QS) regulation (21 CFR Part 820) and misbranded under Section 502(t)(2) due to Medical Device Reporting (MDR) failures (21 CFR Part 803).

Significant QS violations included inadequate procedures for purchasing controls (21 CFR 820.50(a)), complaint handling (21 CFR 820.198(a)), design controls (21 CFR 820.30(a)), CAPA (21 CFR 820.100(a)), and quality audits (21 CFR 820.22). The firm also failed to maintain Device Master Records (DMRs) (21 CFR 820.181) and Device History Records (DHRs) (21 CFR 820.184). The firm's responses to the FDA 483 were deemed inadequate, often providing draft procedures or lacking implementation evidence.

MDR procedure failures (21 CFR 803.17) involved deficiencies in event identification, review processes, timely report transmission, and record-keeping. Additionally, the firm's practice of 'leasing' its 510(k) clearance to other manufacturers is not recognized by FDA and must cease.

Craftmatic must implement prompt corrective actions and submit a comprehensive written response within 15 business days, detailing corrections, prevention plans, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunctions, civil penalties, and impact on federal contracts and device approvals. The firm is responsible for investigating root causes and ensuring full compliance.