FDA Inspection
Sunnex, LLCSunnex, LLC – FDA Inspection, Jul 3, 2019
Record Details
This FDA Inspection record concerns Sunnex, LLC, with an inspection on July 3, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 812548dd-e6fa-48c3-b7e5-2f3dbdea4595
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095148
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Sunnex, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2023 | Not classified | Atlanta District Office | |
| February 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunnex, LLC
- FDA Inspection 1198971 - 2023-02-27
- FDA Inspection 1162566 - 2022-02-18
- FDA Inspection 1017642 - 2017-07-12
- FDA Inspection 916882 - 2015-02-18
- FDA Inspection 792958 - 2012-07-30
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