FDA Inspection
Spectra Medical Devices, LlcSpectra Medical Devices, Llc – FDA Inspection, Mar 30, 2017
Record Details
This FDA Inspection record concerns Spectra Medical Devices, Llc, with an inspection on March 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fe454525-5f9d-43ca-b33e-4d81f0663a36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007007
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Spectra Medical Devices, Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 4, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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