FDA Inspection
CarboFix Orthopedics, Ltd.CarboFix Orthopedics, Ltd. – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns CarboFix Orthopedics, Ltd., with an inspection on March 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 400f0b70-01ff-471e-b57c-13349aacc5b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004648
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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