FDA Inspection
RMC Orthopedic & Surgical, Inc.RMC Orthopedic & Surgical, Inc. – FDA Inspection, Oct 29, 2015
Record Details
This FDA Inspection record concerns RMC Orthopedic & Surgical, Inc., with an inspection on October 29, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 29, 2015
- Product Type
- Biologics
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ID · c725426a-37d5-41d2-961a-5be50d2bf774
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947320
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of RMC Orthopedic & Surgical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 20, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 28, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 31, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for RMC Orthopedic & Surgical, Inc.
- FDA Inspection 1248952 - 2024-08-26
- FDA Inspection 1114132 - 2019-11-20
- FDA Inspection 1037951 - 2017-12-28
- FDA Inspection 813486 - 2012-12-31
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