Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3005053560.
Observations3
Issue DateJune 17, 2019
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Iradimed Corporation
Location
orlando, Florida, United States
FEI Number
3005053560
Product Type
Devices
Issue Date
June 17, 2019
Country
United States
Inspection History, 2010 to 2019
VAI3
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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