FDA WARNING_LETTER - Curasan AG, Frankfurt Facility - May 11, 2017

The FDA issued a Warning Letter to Curasan AG following a May 8-11, 2017 inspection of their Frankfurt, Germany facility, which manufactures medical devices including Cerasorb Dental and Revios Implant System. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain design validation procedures (21 CFR 820.30(g)). The Osbone Dental DHF lacked design validation, and Curasan's response was inadequate, failing to describe systemic review of existing products or verification of corrective action effectiveness. 2. Failure to control production processes (21 CFR 820.70(a)). No manufacturing procedure existed for a component of IngeniOs HA-Synthetic Bone Particles. The response was inadequate, lacking effectiveness verification for updated procedures and training, and a review of potential adverse events. 3. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)). Eleven out of eleven sampled complaints lacked Medical Device Reporting (MDR) evaluation. The updated procedures provided were deemed inadequate as their effectiveness in assessing MDR reportability was not evaluated.

Additionally, devices were misbranded under 21 U.S.C