FDA Inspection
Alliance Orthopedics, LLCAlliance Orthopedics, LLC – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns Alliance Orthopedics, LLC, with an inspection on May 23, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Alliance Orthopedics, LLC
- Inspection Date
- May 23, 2013
- Product Type
- Biologics
View Company Profile
ID · afdcc042-d199-471c-9de7-738a8c0f9602
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834037
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.265(c)(1)Release of HCT/Ps by responsible person
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of Alliance Orthopedics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Alliance Orthopedics, LLC
- FDA Inspection 664321 - 2010-05-25
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