FDA Inspection
Spinergy, Inc (SM Power LLC)Spinergy, Inc (SM Power LLC) – FDA Inspection, May 8, 2019
Record Details
This FDA Inspection record concerns Spinergy, Inc (SM Power LLC), with an inspection on May 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aeb9acb2-3bbd-4577-8a93-b396880b5cd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088917
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Spinergy, Inc (SM Power LLC)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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