483
Dentorium Products Co. Inc.FDA 483 - Dentorium Products Co. Inc. - July 30, 2019
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Record Details
An FDA inspection of Dentorium Products Co. Inc., a medical device importer and repackager in Farmingdale, NY, identified one observation. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures. This indicates a significant deficiency in their quality system regarding adverse event reporting.
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ID · 8aec3ab2-0221-4281-808b-9b7a33782352