Company
United StatesColoplast Manufacturing US, LLC, Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Coloplast Manufacturing US, LLC in Minneapolis, Minnesota. 12 FDA inspections on record, 1 Form 483, last inspected March 06, 2026.
Company Profile
This profile covers Coloplast Manufacturing US, LLC based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 3
- NAI
- 8
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 14, 2009. Last inspected March 6, 2026.
Most cited issue areas
- Design verification - documentation1 inspection
- Sponsor correspondence records inadequate1 inspection
- Sponsors" general responsibilities1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2026 | Not classified | Medical Devices & Rad Health | 1307530 |
| January 20, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1196697 |
| February 6, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1080994 |
| September 25, 2018 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1066755 |
| September 14, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1068220 |
| November 9, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 997753 |
| November 24, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 951146 |
| July 11, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 790075 |
| December 14, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 759709 |
| September 28, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 744306 |
| December 18, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 635354 |
| October 14, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 624846 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Coloplast Manufacturing US, LLC
FEI Number
2125050
Address
1601 W River Rd, Minneapolis, Minnesota 55411, United States
Country
United States
ID: fbedee38-0734-4861-b976-f0edc069d101