FDA Inspection
FloSpine, LLCFloSpine, LLC – FDA Inspection, Sep 29, 2016
Record Details
This FDA Inspection record concerns FloSpine, LLC, with an inspection on September 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- FloSpine, LLC
- Inspection Date
- September 29, 2016
- Product Type
- Devices
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ID · adef9bcf-7b60-43e6-8630-905dc8f3d2da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987962
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of FloSpine, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| November 18, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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