FDA Inspection
Amo Groningen BVAmo Groningen BV – FDA Inspection, Feb 13, 2014
Record Details
This FDA Inspection record concerns Amo Groningen BV, with an inspection on February 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amo Groningen BV
- Inspection Date
- February 13, 2014
- Product Type
- Devices
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ID · 2353bdce-685c-4d91-ba58-098e2d762cc1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 870154
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of Amo Groningen BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2019 | 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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