FDA WARNING_LETTER - Heartsine Technologies, LTD - November 29, 2007

The FDA issued a Warning Letter to Heartsine Technologies, LTD. following an inspection from November 26-29, 2007, in Belfast, Northern Ireland. The inspection revealed that the firm's Samaritan Automatic External Defibrillator (AED) and Samaritan Public Access Defibrillator (PAD) devices are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Key violations include inadequate procedures for device design validation (21 CFR 820.30(g)), incoming product acceptance (21 CFR 820.80(b)), labeling control (21 CFR 820.120), sampling methods (21 CFR 820.250(h)), and complaint handling (21 CFR 820.198(a)), as well as insufficient personnel training (21 CFR 820.25(h)). Additionally, the Samaritan PAD is misbranded due to lacking the required caution statement for prescription devices (21 CFR 801.109(h)). The firm's previous responses were deemed inadequate. Heartsine Technologies must promptly correct these violations and notify the FDA within 15 working days with specific steps, preventative measures, documentation, and a timetable. Failure to comply may result in device detention, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments. A follow-up inspection will be required.