FDA Inspection
EUSA Global, LLCEUSA Global, LLC – FDA Inspection, Dec 9, 2014
Record Details
This FDA Inspection record concerns EUSA Global, LLC, with an inspection on December 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EUSA Global, LLC
- Inspection Date
- December 9, 2014
- Product Type
- Devices
View Company Profile
ID · a7bd0913-a5cc-4aa0-9967-d6c5983c9e11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906893
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of EUSA Global, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| March 22, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 15, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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