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 3014732157.
Observations4
Issue DateAugust 08, 2025
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Fresenius Kabi USA, LLC
Location
North Andover, Massachusetts
FEI Number
3014732157
Product Type
Devices
Issue Date
August 08, 2025
Country
United States
Inspection History, 2022 to 2025
NAI1
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.