FDA WARNING_LETTER - Heartsine Technologies Inc - August 04, 2009

This FDA Warning Letter, dated October 26, 2009, was issued to Heartsine Technologies Inc. following an inspection from July 23 to August 4, 2009, in Newtown, Pennsylvania. The firm manufactures Class III Automatic External Defibrillator (AED) devices.

The inspection revealed the AED devices are misbranded under Section 502(t)(2) of the Act due to failures in Medical Device Tracking Requirements (21 C.F.R. Part 821) and Medical Device Reporting (MDR) regulations (21 C.F.R. Part 803).

Key violations include: 1. **Medical Device Tracking (21 C.F.R. 821.25):** * Failure to keep current records of distributor/patient information for tracked devices. The firm could not produce tracking information for (b)(4) devices, and their procedure only required distributors to provide information upon request, not upon receipt. * Failure to establish a procedure for recording missing tracking data and reasons for its absence. * Failure to conduct tracking system audits at required intervals (last audit on (b)(4), subsequent audit not conducted by inspection date).

2. **Medical Device Reporting (21 C.F.R. Part 803):** * Failure to investigate each event and evaluate