FDA Inspection
Spectra Medical Devices, LlcSpectra Medical Devices, Llc – FDA Inspection, May 4, 2012
Record Details
This FDA Inspection record concerns Spectra Medical Devices, Llc, with an inspection on May 4, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Spectra Medical Devices, Llc
- Inspection Date
- May 4, 2012
- Product Type
- Drugs
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ID · f2ceefce-28cd-43f8-acd1-4c9ac133db0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779912
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| March 30, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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