FDA Inspection
Reflexonic, LLCReflexonic, LLC – FDA Inspection, Oct 17, 2018
Record Details
This FDA Inspection record concerns Reflexonic, LLC, with an inspection on October 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9cf57c7c-0b12-46e2-bbda-c7426ed1d5af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069061
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Reflexonic, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2025 | Not classified | Baltimore District Office | Compliance: Medical Devices |
| April 19, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Reflexonic, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.