FDA WARNING_LETTER - Zyno Medical LLC - February 15, 2022

An FDA inspection from January 29 to February 15, 2022, at 177 Pine Street, Natick, MA, revealed significant violations for a manufacturer of infusion pumps and administration sets. The firm's devices, including Z-800 series infusion systems, were found to be adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Additionally, administration sets were misbranded under 502(t)(2) for failing to furnish Medical Device Reporting (MDR) information, adulterated under 501(f)(1)(B) for lacking an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE), and misbranded under 502(o) for not submitting a 510(k) notification. Specific QS violations included inadequate procedures for corrective and preventive actions (21 CFR 820.100(a)), insufficient design change controls (21 CFR 820.30(i)), and failure to adequately investigate complaints (21 CFR § 820.198(c)). The firm also failed to submit timely malfunction MDRs (21 CFR 803.50(a)(2)). While the firm submitted multiple responses outlining corrective actions like procedure revisions, new CAPAs, retrospective reviews, and additional MDRs, the FDA found the adequacy of these responses undetermined as actions were incomplete and timeframes were not provided. The firm must respond within fifteen business days with specific steps, documentation, and a timetable for completion to prevent further regulatory actions, including seizure, injunction, civil money penalties, and impacts on federal contracts or device approvals.