FDA inspection
Coloplast Manufacturing US, LLC: FDA inspection ending Sep 14, 2018
FDA inspection 1068220 · No Action Indicated (NAI) · Minneapolis, Minnesota
Key facts
| Inspection ID | 1068220 |
|---|---|
| Firm | Coloplast Manufacturing US, LLC |
| FEI number | 2125050 |
| Address | 1601 W River Rd |
| City | Minneapolis |
| State | Minnesota |
| ZIP | 55411 |
| Fiscal year | 2018 |
| Inspection end date | Sep 14, 2018 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med 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| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data