FDA Inspection
Medical Illumination International, IncMedical Illumination International, Inc – FDA Inspection, Aug 13, 2013
Record Details
This FDA Inspection record concerns Medical Illumination International, Inc, with an inspection on August 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 13, 2013
- Product Type
- Devices
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ID · 8676d978-8e55-4ea9-b09a-eb359b4674d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845185
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Medical Illumination International, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2025 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| August 5, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Illumination International, Inc
- FDA Inspection 1259484 - 2025-01-29
- FDA Inspection 1148371 - 2021-08-05
- FDA Inspection 1038557 - 2018-01-24
- FDA Inspection 934453 - 2015-07-23
- FDA Inspection 656914 - 2010-03-31
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