FDA WARNING_LETTER - Q'apel Medical, Inc. - August 08, 2024

An FDA inspection of Q’Apel Medical in Fremont, CA, from July 29 to August 8, 2024, revealed significant violations regarding their 072 Aspiration System (HIPPO). The device is deemed adulterated under section 501(f)(1)(B) of the Act for lacking an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Specifically, the firm marketed a modified device with a nitinol tip capable of diameter and length changes, which significantly affects safety or effectiveness, without seeking new clearance or approval as required by 21 CFR 807.81(a)(3). Furthermore, the inspection identified that the device is adulterated under section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Key QS violations include inadequate documentation of design input requirements (21 CFR 820.30(c)), failure to establish and maintain design verification procedures (21 CFR 820.30(f)), inadequate design change procedures (21 CFR 820.30(i)), insufficient procedures for complaint handling (21 CFR 820.198(a)), and failure to adequately establish and maintain document control procedures (21 CFR 820.40). The firm's responses to the FDA 483 observations were largely deemed inadequate. Q’Apel Medical must cease commercial distribution of the non-compliant device and provide a comprehensive response within fifteen business days detailing corrective actions, including a timetable for systemic changes. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts and future device approvals.