FDA Inspection
Bolder Surgical, LLCBolder Surgical, LLC – FDA Inspection, Nov 27, 2017
Record Details
This FDA Inspection record concerns Bolder Surgical, LLC, with an inspection on November 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb25a160-fdee-4bb6-8ace-fc29aab9a0b9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1032115
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Bolder Surgical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bolder Surgical, LLC
- FDA Inspection 1194205 - 2022-12-14
- FDA Inspection 907576 - 2014-12-18
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