FDA Inspection
Modern Orthopedic ConsultantsModern Orthopedic Consultants – FDA Inspection, May 30, 2012
Record Details
This FDA Inspection record concerns Modern Orthopedic Consultants, with an inspection on May 30, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 30, 2012
- Product Type
- Biologics
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ID · bc500050-052d-42c6-a276-6b56acae3132
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783861
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(3)Actions taken and documented
- 21 CFR 1271.160(b)(4)Training of personnel
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Other FDA inspections of Modern Orthopedic Consultants
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 30, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 5, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Modern Orthopedic Consultants
- FDA Inspection 860691 - 2013-12-30
- FDA Inspection 675803 - 2010-08-05
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