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 1713747.
Observations1
Issue DateMay 21, 2021
Status1 Related Warning Letter
Related Inspections10
Establishment Details
Firm
Fresenius Medical Care, North America
Location
Ogden, Utah, United States
FEI Number
1713747
Product Type
Devices
Issue Date
May 21, 2021
Country
United States
Inspection History, 2011 to 2026
NAI2
VAI6
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.