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 2125050.
Observations1
Issue DateSeptember 25, 2018
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Coloplast Manufacturing US, LLC
Location
Minneapolis, Minnesota, United States
FEI Number
2125050
Product Type
Devices
Issue Date
September 25, 2018
Country
United States
Inspection History, 2011 to 2026
NAI8
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.