FDA WARNING_LETTER - Medinol Ltd. - March 27, 2014

On July 29, 2014, the FDA issued a Warning Letter to Medinol, LTD. following an inspection from March 23-27, 2014, at their Jerusalem, Israel facility, which manufactures the Presillion Plus CoCr Stent and Delivery System. The inspection revealed the device was misbranded under section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) as required by 21 CFR Part 803.

Key violations included: 1. **Failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17(a))**: The firm's "Complaint Reporting to US" procedure (Revision #5 and #6) lacked definitions for "become aware," "caused or contributed," and "reasonably suggests," potentially leading to incorrect reportability decisions. It also failed to include instructions for obtaining and completing the FDA 3500A form. 2. **Failure to submit timely supplemental or follow-up reports (21 CFR 803.56)**: An investigation report for MDR 9710284-2012-00001 (Complaint PP128) was not submitted within one month of obtaining new information. 3. **Failure to report malfunctions within 30 days (21 CFR 80