FDA Inspection
OrthoPlus IncOrthoPlus Inc – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns OrthoPlus Inc, with an inspection on January 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OrthoPlus Inc
- Inspection Date
- January 15, 2010
- Product Type
- Biologics
View Company Profile
ID · b947e5bf-ef72-4d0f-9816-cb11ffb69117
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638742
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
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