FDA Inspection
Advanced Institute for Infertility, S.C.Advanced Institute for Infertility, S.C. – FDA Inspection, Jun 21, 2013
Record Details
This FDA Inspection record concerns Advanced Institute for Infertility, S.C., with an inspection on June 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 21, 2013
- Product Type
- Biologics
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ID · dbe4ebc1-5b0d-4f2c-bae0-859dc54a0e99
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836637
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Advanced Institute for Infertility, S.C.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Advanced Institute for Infertility, S.C.
- FDA Inspection 862283 - 2014-01-15
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