FDA Inspection
Reflexonic, LLCReflexonic, LLC – FDA Inspection, Apr 19, 2016
Record Details
This FDA Inspection record concerns Reflexonic, LLC, with an inspection on April 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Reflexonic, LLC
- Inspection Date
- April 19, 2016
- Product Type
- Devices
View Company Profile
ID · 9535bc86-2ae8-4581-aef4-9b856e1dc5a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968449
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Reflexonic, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2025 | Not classified | Baltimore District Office | Compliance: Medical Devices |
| October 17, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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