FDA Inspection
Eurotrol B. V.Eurotrol B. V. – FDA Inspection, May 6, 2016
Record Details
This FDA Inspection record concerns Eurotrol B. V., with an inspection on May 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eurotrol B. V.
- Inspection Date
- May 6, 2016
- Product Type
- Devices
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ID · 1dfd1cf2-0cc9-4bbc-80b7-db71db63658e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972348
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Eurotrol B. V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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