FDA Inspection
Aspire Fertility Institute DallasAspire Fertility Institute Dallas – FDA Inspection, Jul 12, 2023
Record Details
This FDA Inspection record concerns Aspire Fertility Institute Dallas, with an inspection on July 12, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 82b3eed2-1011-4416-a134-4aaacb04a2f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210012
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
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Other FDA inspections of Aspire Fertility Institute Dallas
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 22, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Aspire Fertility Institute Dallas
- FDA Inspection 1259652 - 2025-01-23
- FDA Inspection 1064726 - 2018-08-22
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