483
Frostime LlcFrostime Llc – FDA 483, Oct 28, 2020
Record Details
During an inspection, the FDA cited Frostime Llc, a manufacturer in New York, NY, for failing to maintain adequate procedures. The firm lacked electronic Medical Device Reporting (eMDR) procedures necessary for handling death and serious injury incidents. This indicates a significant lapse in their regulatory compliance regarding adverse event reporting.
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ID · 7dbba5f3-e6fc-4550-b602-5e6637360c1e
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