FDA Inspection
Orthopaedic Technologies, LLCOrthopaedic Technologies, LLC – FDA Inspection, Jan 9, 2009
Record Details
This FDA Inspection record concerns Orthopaedic Technologies, LLC, with an inspection on January 9, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 9, 2009
- Product Type
- Biologics
View Company Profile
ID · efe96387-9693-46e6-8a4b-3779cbe0536b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 556337
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
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Other FDA inspections of Orthopaedic Technologies, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Orthopaedic Technologies, LLC
- FDA Inspection 695112 - 2010-10-26
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