FDA Inspection
Sperm Bank, Inc. dba Fertility Center of CaliforniaSperm Bank, Inc. dba Fertility Center of California – FDA Inspection, Sep 29, 2023
Record Details
This FDA Inspection record concerns Sperm Bank, Inc. dba Fertility Center of California, with an inspection on September 29, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 29, 2023
- Product Type
- Biologics
View Company Profile
ID · 84a50525-a57f-4eeb-a02d-62cda745bb5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219185
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sperm Bank, Inc. dba Fertility Center of California
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | Not classified | Los Angeles District Office | Blood and Blood Products |
| January 4, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 4, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 2, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Sperm Bank, Inc. dba Fertility Center of California
- FDA Inspection 1249000 - 2024-09-11
- FDA Inspection 1037295 - 2018-01-04
- FDA Inspection 950096 - 2015-11-04
- FDA Inspection 771176 - 2012-03-08
- FDA Inspection 679892 - 2010-09-02
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