FDA 483 - Wittenstein intens GmbH - March 11, 2019

An FDA inspection of Wittenstein intens GmbH, a device manufacturer in Harthausen, Germany, revealed two significant observations. The firm failed to submit a Medical Device Report (MDR) within 30 days for a malfunctioning Fitbone device. Additionally, the validation of the laser welding process for the Fitbone device was found to be inadequate, with testing involving only two pieces and one failing to meet acceptance criteria.