FDA Inspection
REACT InnovationsREACT Innovations – FDA Inspection, Feb 17, 2023
Record Details
This FDA Inspection record concerns REACT Innovations, with an inspection on February 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cf6e54bf-48e1-402b-8735-b6af2485017a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198459
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 820.100(b)Documentation
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Showing 10 of 17 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of REACT Innovations
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2026 | Not classified | Atlanta District Office | Compliance: Medical Devices |
Other documents for REACT Innovations
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.