FDA Inspection
FSAC Fertility, Inc. dba Fertility & Surgical Medical Associates of CaliforniaFSAC Fertility, Inc. dba Fertility & Surgical Medical Associates of California – FDA Inspection, Jul 30, 2018
Record Details
This FDA Inspection record concerns FSAC Fertility, Inc. dba Fertility & Surgical Medical Associates of California, with an inspection on July 30, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 30, 2018
- Product Type
- Biologics
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ID · b43f90d0-dfcd-43fe-b15e-a22707f43266
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060833
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
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Other FDA inspections of FSAC Fertility, Inc. dba Fertility & Surgical Medical Associates of California
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 14, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 29, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 15, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for FSAC Fertility, Inc. dba Fertility & Surgical Medical Associates of California
- FDA Inspection 1311752 - 2026-04-07
- FDA Inspection 1208364 - 2023-06-14
- FDA Inspection 826190 - 2013-03-29
- FDA Inspection 745746 - 2011-09-15
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