FDA Inspection
Reproductive Institute of South TexasReproductive Institute of South Texas – FDA Inspection, Apr 16, 2018
Record Details
This FDA Inspection record concerns Reproductive Institute of South Texas, with an inspection on April 16, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 669c527d-1bc0-42ad-93a6-36199363f709
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048356
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(c)Name and personal info on accompanying records
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Other FDA inspections of Reproductive Institute of South Texas
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 7, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 16, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 10, 2012 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Institute of South Texas
- FDA Inspection 1175277 - 2022-07-11
- FDA Inspection 960804 - 2016-01-07
- FDA Inspection 844699 - 2013-08-16
- FDA Inspection 794470 - 2012-08-10
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