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

Source: https://www.keypedia.com/records/warning_letter/applied-medical-resources-corp/9a1f0879-a13f-4a2f-91ac-0943f1aaf578

> FDA WARNING_LETTER for Applied Medical Resources Corp on December 16, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Applied Medical Resources Corp
- Inspection Date: 2014-12-16
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Chief. Environmental Program Manager I](https://www.keypedia.com/people/david-mazzera/7fdf231f-4a08-4f88-b6f9-cc9b9b04eaea)

Company: https://www.keypedia.com/companies/applied-medical-resources-corp/7e63d8f6-1a0d-457e-8cd2-899df474beab

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b