Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2125050.
Observations1
Issue DateSeptember 28, 2011
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 28, 2011
Country
United States
Inspection History, 2011 to 2026
NAI8
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.