FDA Inspection
Coloplast Manufacturing US, LLCColoplast Manufacturing US, LLC – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns Coloplast Manufacturing US, LLC, with an inspection on September 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8c4626f-964e-4440-9cae-4f3f1e99c904
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066755
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
Full citation text and observation details available on the Dashboard.
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 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 9, 2016 | 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 1068220 - 2018-09-14
- FDA Inspection 997753 - 2016-11-09
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