FDA Inspection
DynaFlexDynaFlex – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns DynaFlex, with an inspection on March 6, 2026, issued by the Kansas City District Office, covering medical devices & rad health.
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ID · 9f9a3483-b6d0-4be9-a38f-109970e27856
Inspection Facts
- Inspection number
- 1305824
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
- ISO 13485:2016 Clause 7.6Equipment calibration or verification not performed
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Other FDA inspections of DynaFlex
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 18, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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