FDA Inspection
Spectramed LLCSpectramed LLC – FDA Inspection, Oct 26, 2022
Record Details
This FDA Inspection record concerns Spectramed LLC, with an inspection on October 26, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spectramed LLC
- Inspection Date
- October 26, 2022
- Product Type
- Devices
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ID · 728fb88e-9a37-4c94-ba76-6c4778abad27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spectramed LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 7, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spectramed LLC
- FDA Inspection 1114507 - 2019-12-11
- FDA Inspection 840639 - 2013-07-23
- FDA Inspection 579046 - 2009-05-07
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