FDA WARNING_LETTER - Applied Medical Resources Corp - December 16, 2014

On April 10, 2015, the FDA issued a Warning Letter to Applied Medical Resources Corp following an inspection from November 3 to December 16, 2014. The inspection revealed the company's medical devices, used in various surgeries, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to implement CAPA procedures (21 CFR 820.100(a)(3)):** Inadequate analysis of quality data for Suction/Irrigator and Kii Trocar complaints, leading to unaddressed non-conformities and unverified/unvalidated CAPAs. 2. **Failure to investigate complaints (21 CFR 820.198(c)):** Inadequate root cause investigation for device failures, including patient deaths and serious injuries linked to Kii Shield Bladed System, Epix Universal Clip, and Suction/Irrigator. Test methods, raw data, and trending were insufficient. 3. **Failure in design verification (21 CFR 820.30(f)):** Design output test results for Kii Shielded Bladed Access System lacked raw data, rationale for safety factors, and justification for changes in acceptance criteria. 4.