FDA Inspection
Amo Groningen BVAmo Groningen BV – FDA Inspection, Nov 13, 2019
Record Details
This FDA Inspection record concerns Amo Groningen BV, with an inspection on November 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amo Groningen BV
- Inspection Date
- November 13, 2019
- Product Type
- Devices
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ID · fabbbf0e-836f-4493-b131-c84f57a69756
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111640
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Amo Groningen BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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