FDA Inspection
DynaFlexDynaFlex – FDA Inspection, Sep 25, 2023
Record Details
This FDA Inspection record concerns DynaFlex, with an inspection on September 25, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f73cc413-96b2-4adc-ad9e-f84ea9421dc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218587
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of DynaFlex
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | Kansas City District Office | Compliance: Medical 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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