483
NanoHive MedicalNanoHive Medical – FDA 483, Mar 5, 2026
Record Details
An FDA inspection of Nanohive Medical LLC in Woburn, MA, a medical device manufacturer, revealed significant deficiencies in their complaint handling system. The firm failed to adequately maintain complaint records, with issues including missing signatures, incomplete documentation for regulatory reporting, lack of corrective action references, and untimely processing of complaints.
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