FDA Inspection
Spectrum International, Inc.Spectrum International, Inc. – FDA Inspection, Jun 6, 2018
Record Details
This FDA Inspection record concerns Spectrum International, Inc., with an inspection on June 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6d23c43-c153-4956-a067-dfb947ca67a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055308
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spectrum International, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spectrum International, Inc.
- FDA Inspection 862900 - 2014-01-22
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