FDA Inspection
Coloplast Manufacturing US, LLCColoplast Manufacturing US, LLC – FDA Inspection, Sep 28, 2011
Record Details
This FDA Inspection record concerns Coloplast Manufacturing US, LLC, with an inspection on September 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 28, 2011
- Product Type
- Devices
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ID · 475b00d7-580d-455d-bda5-99543e58b16d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 744306
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Coloplast Manufacturing US, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | Minneapolis District Office | |
| January 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 6, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 25, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Coloplast Manufacturing US, LLC
- FDA Inspection 1307530 - 2026-03-06
- FDA Inspection 1196697 - 2023-01-20
- FDA Inspection 1080994 - 2019-02-06
- FDA Inspection 1066755 - 2018-09-25
- FDA Inspection 1068220 - 2018-09-14
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