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

Source: https://www.keypedia.com/records/warning_letter/medart-as/085ad20a-dcc9-4807-b25f-97db88c6504b

> FDA WARNING_LETTER for Medart A/S on June 01, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Medart A/S
- Inspection Date: 2012-06-01
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Olav Balle-Petersen](https://www.keypedia.com/people/olav-balle-petersen/b21391b4-12a6-43a7-99d8-7dad47ad8074)

Company: https://www.keypedia.com/companies/medart-as/ac5d81dc-bd9a-40e5-9cbf-724aa3f16fd9

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861