FDA WARNING_LETTER - Contract Medical International Spol. S.o.r. - August 09, 2012

On August 7-9, 2012, an FDA inspection of Contract Medical International Spol. S.o.r. in Hradec Kralove, Czech Republic, revealed that their Biotronik Fortress Introducer Sheath System devices were 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).

Key violations included: 1. **Failure to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17(a)(1))**: The firm's procedure MFB-004 Rev: 0 lacked internal systems for timely identification, communication, and evaluation of events subject to MDR, and did not define reportable events based on 21 CFR Part 803 terms. 2. **Failure to report serious injuries within 30 calendar days (21 CFR 803.50(a)(1))**: Complaints PC11020 and PC11026, where sheaths broke and required surgical removal from patients, were not reported as serious injuries. The firm's rationale that incidents occurred outside the US market and device contribution wasn't proven was deemed insufficient, as foreign events involving similar US-marketed devices are reportable.

Additionally, the firm