FDA Inspection
Spinergy, Inc (SM Power LLC)Spinergy, Inc (SM Power LLC) – FDA Inspection, Aug 15, 2023
Record Details
This FDA Inspection record concerns Spinergy, Inc (SM Power LLC), with an inspection on August 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f60bfde5-263f-49c5-a3ba-732f1135f4a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1214876
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Spinergy, Inc (SM Power LLC)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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