FDA Inspection
REACT InnovationsREACT Innovations – FDA Inspection, Mar 5, 2026
Record Details
This FDA Inspection record concerns REACT Innovations, with an inspection on March 5, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · cbee1283-5de1-4f9a-9579-382352c5632c
Inspection Facts
- Inspection number
- 1305766
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
- ISO 13485:2016 Clause 7.5.4Records of servicing activities not maintained
- 21 CFR 820.35(c)UDI was not recorded for each medical device or batch
- ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
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Other FDA inspections of REACT Innovations
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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