FDA Inspection
Texas Tech University Health Sciences Center Center for Fertility and Reproductive SurgeryTexas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery – FDA Inspection, Jul 26, 2023
Record Details
This FDA Inspection record concerns Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery, with an inspection on July 26, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 26, 2023
- Product Type
- Biologics
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ID · de8f49d0-7ed3-44ca-b853-5f03e58dcb0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210976
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
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Other FDA inspections of Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2026 | Not classified | Dallas District Office | |
| September 21, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 14, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 13, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery
- FDA Inspection 1331342 - 2026-07-27
- FDA Inspection 1179966 - 2022-09-21
- FDA Inspection 998282 - 2016-12-14
- FDA Inspection 835672 - 2013-06-13
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