483
Micro Medical Solutions, Inc.Micro Medical Solutions, Inc. – FDA 483, Jul 2, 2025
Record Details
An FDA inspection of Micro Medical Solutions, Inc. in Woburn, MA, identified a significant issue regarding the monitoring of an investigational study. The firm, acting as a sponsor, failed to ensure that images collected from study sites met the requirements for adequate review by the Core Laboratory. This lapse resulted in a substantial number of non-diagnostic images, hindering proper evaluation of target lesions.
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ID · 44ae6ca2-611d-4d9b-8c74-31c61d622d05
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