FDA Inspection
Family Fertility CenterFamily Fertility Center – FDA Inspection, Jun 26, 2019
Record Details
This FDA Inspection record concerns Family Fertility Center, with an inspection on June 26, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a0e1c8fc-52c6-4bd4-b4e6-971524571b42
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1094952
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
5- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(d)(4)Ten year retention
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Family Fertility Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 16, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Family Fertility Center
- FDA Inspection 1228642 - 2024-01-30
- FDA Inspection 1121860 - 2020-03-16
- FDA Inspection 925203 - 2015-05-06
- FDA Inspection 787155 - 2012-05-23
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