483
MESI D.O.O.FDA 483 - MESI D.O.O. - February 07, 2019
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Record Details
An FDA inspection of MESI D.O.O., a medical device manufacturer in Ljubljana, Slovenia, from February 4-7, 2019, identified one significant observation. The firm was cited for failing to develop and implement written Medical Device Reporting (MDR) procedures. This indicates a deficiency in their post-market surveillance system.
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ID · c1598d14-da94-444d-a3a2-728e4a3002ae