FDA Inspection
Texas Center for Reproductive HealthTexas Center for Reproductive Health – FDA Inspection, Feb 4, 2016
Record Details
This FDA Inspection record concerns Texas Center for Reproductive Health, with an inspection on February 4, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 4, 2016
- Product Type
- Biologics
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ID · 06418a3f-b98a-4a06-b976-20722b69c28e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 957609
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.90(c)Eligibility not required--warning labels
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Texas Center for Reproductive Health
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2025 | Not classified | Dallas District Office | |
| November 7, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 12, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 20, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Texas Center for Reproductive Health
- FDA Inspection 1263527 - 2025-03-06
- FDA Inspection 1073733 - 2018-11-07
- FDA Inspection 818101 - 2013-02-12
- FDA Inspection 665565 - 2010-05-20
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