FDA Inspection
COMECER NETHERLANDS B.V.COMECER NETHERLANDS B.V. – FDA Inspection, Sep 8, 2022
Record Details
This FDA Inspection record concerns COMECER NETHERLANDS B.V., with an inspection on September 8, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- COMECER NETHERLANDS B.V.
- Inspection Date
- September 8, 2022
- Product Type
- Devices
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ID · d7e4d2f7-f9c0-4709-826a-7aea0f0d1a71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180920
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of COMECER NETHERLANDS B.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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