FDA Inspection
UT Regional One Reproductive MedicineUT Regional One Reproductive Medicine – FDA Inspection, Mar 17, 2016
Record Details
This FDA Inspection record concerns UT Regional One Reproductive Medicine, with an inspection on March 17, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 17, 2016
- Product Type
- Biologics
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ID · e6774df8-ff0f-4284-8217-47d251951ed8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966850
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of UT Regional One Reproductive Medicine
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 28, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for UT Regional One Reproductive Medicine
- FDA Inspection 1043298 - 2018-02-14
- FDA Inspection 883623 - 2014-05-28
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