FDA Inspection
VALLEY ELECTRONICS AGVALLEY ELECTRONICS AG – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns VALLEY ELECTRONICS AG, with an inspection on September 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · d608bd26-508e-4777-9edb-98dae88fd792
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1105924
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of VALLEY ELECTRONICS AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 11, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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