FDA Inspection
Finsbury OrthopaedicsFinsbury Orthopaedics – FDA Inspection, Apr 28, 2010
Record Details
This FDA Inspection record concerns Finsbury Orthopaedics, with an inspection on April 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Finsbury Orthopaedics
- Inspection Date
- April 28, 2010
- Product Type
- Devices
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ID · a9a3db1b-899f-49dc-94a0-6286a7798fc3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661646
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
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