FDA Inspection
Implantes y Sistemas Medicos Inc.Implantes y Sistemas Medicos Inc. – FDA Inspection, May 30, 2012
Record Details
This FDA Inspection record concerns Implantes y Sistemas Medicos Inc., 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 · 34048d47-5e22-4e28-92b3-d1efa089163c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784191
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Implantes y Sistemas Medicos Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 13, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Implantes y Sistemas Medicos Inc.
- FDA Inspection 1003667 - 2017-03-08
- FDA Inspection 925641 - 2015-05-13
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