FDA Inspection
CurvaFix, Inc.CurvaFix, Inc. – FDA Inspection, Aug 23, 2023
Record Details
This FDA Inspection record concerns CurvaFix, Inc., with an inspection on August 23, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f2a24fae-afec-4714-801e-b9f21010a3c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215697
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of CurvaFix, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2025 | NAI | Seattle District Office | Postmarket Assurance: Medical Devices |
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