483
Wittenstein intens GmbHWittenstein intens GmbH – FDA 483, Mar 11, 2019
Record Details
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.
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ID · 26029b05-2f88-4af2-8ffa-d56034d7c1cd
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