FDA Inspection
US Orthopedics IncUS Orthopedics Inc – FDA Inspection, Apr 19, 2017
Record Details
This FDA Inspection record concerns US Orthopedics Inc, with an inspection on April 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d298195c-da15-4b30-bcc4-fd96db94cf88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012876
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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