FDA Inspection
USI Orthopaedics, LLCUSI Orthopaedics, LLC – FDA Inspection, Apr 6, 2011
Record Details
This FDA Inspection record concerns USI Orthopaedics, LLC, with an inspection on April 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- USI Orthopaedics, LLC
- Inspection Date
- April 6, 2011
- Product Type
- Devices
View Company Profile
ID · 89e51277-c755-48fc-9274-80933ee66b89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718287
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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