Company
DenmarkColoplast A/S, Humlebak, Denmark – FDA Inspections
Inspection records and compliance data for Coloplast A/S in Humlebak. 3 FDA inspections on record, 1 Form 483, last inspected April 13, 2018.
Company Profile
This profile covers Coloplast A/S based in Humlebak, Denmark.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 12, 2015. Last inspected April 13, 2018.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Design validation - production units1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 13, 2018 | Not classified | Medical Devices & Rad Health | 1085915 |
| September 1, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1024792 |
| March 12, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 929019 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Coloplast A/S
FEI Number
3002806731
Address
Holtedam 1, Humlebak, Denmark
Country
Denmark
ID: 635b8af2-1476-4036-b6d9-c19302872a6d