FDA Inspection
Bonafix Surgical and Dental Implants, LLCBonafix Surgical and Dental Implants, LLC – FDA Inspection, Mar 11, 2019
Record Details
This FDA Inspection record concerns Bonafix Surgical and Dental Implants, LLC, with an inspection on March 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9d9412db-29ae-4807-a9d7-55203f00c20d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082391
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
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Other FDA inspections of Bonafix Surgical and Dental Implants, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bonafix Surgical and Dental Implants, LLC
- FDA Inspection 916489 - 2015-02-27
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