FDA Inspection
Archus Orthopedics Inc.Archus Orthopedics Inc. – FDA Inspection, Nov 14, 2008
Record Details
This FDA Inspection record concerns Archus Orthopedics Inc., with an inspection on November 14, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Archus Orthopedics Inc.
- Inspection Date
- November 14, 2008
- Product Type
- Devices
View Company Profile
ID · da74817f-39d6-4347-8da4-41810713c491
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 549011
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
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