FDA WARNING_LETTER - APC Medical Limited - September 22, 2011

On September 19-22, 2011, an FDA inspection of APC Medical Limited in Welwyn Garden City, UK, revealed violations regarding their Temporary Cardiac Pacer Extension Cables, Pacer Analyzer Cables, and Temporary Cardiac Pacers. The devices were deemed misbranded under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Specific violations include: 1. **Failure to develop, maintain, and implement written MDR procedures (21 CFR Part 803.17).** The firm's procedure (b)(4) was a complaint handling process, not an MDR procedure. 2. **Failure to submit MDRs for reportable deaths, serious injuries, or malfunctions (21 CFR Part 803.50).** 3. **Failure to fulfill annual establishment registration and device listing requirements for fiscal year 2011 (21 U.S.C. § 360).** This resulted in devices being misbranded under section 502(o) of the Act.

Additionally, the firm's quality system had deficiencies under 21 CFR Part 820 (Quality System regulation): 1. **Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR