FDA Inspection
C.A.R.E. FertilityC.A.R.E. Fertility – FDA Inspection, Oct 26, 2023
Record Details
This FDA Inspection record concerns C.A.R.E. Fertility, with an inspection on October 26, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e02f6f84-dd1a-4465-a31c-71591201103d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221152
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.55(d)(4)Ten year retention
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.55(d)(4)Ten year retention
- 21 CFR 1271.60(a)Completion of eligibility determination
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Other FDA inspections of C.A.R.E. Fertility
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 20, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 28, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for C.A.R.E. Fertility
- FDA Inspection 1085960 - 2019-04-11
- FDA Inspection 839416 - 2013-06-20
- FDA Inspection 682789 - 2010-09-28
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