FDA WARNING_LETTER - Medart A/S - June 01, 2012

On November 19, 2012, the FDA issued a Warning Letter to MedArt A/S following an inspection from May 29 to June 1, 2012, at their Hvidovre, Denmark facility, which manufactures medical laser devices. The inspection revealed that MedArt A/S's devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to failure to furnish required information under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR).

Key violations include:

1. **Inadequate MDR Procedures (21 CFR 803.17):** MedArt A/S failed to establish internal systems for standardized review, investigation, and timely transmission of complete MDRs. Their procedure (106442 v2) lacked instructions for event investigation, timely reportability determinations, and proper documentation/record-keeping. The provided web address for the MedWatch 3500A form was incorrect. MedArt A/S's responses were deemed inadequate as the revised procedure still contained the incorrect web address, and submitted evaluation forms lacked sufficient information for reportability determination.

2. **Quality System