FDA Inspection
Reproductive Institute of South TexasReproductive Institute of South Texas – FDA Inspection, Aug 16, 2013
Record Details
This FDA Inspection record concerns Reproductive Institute of South Texas, with an inspection on August 16, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 16, 2013
- Product Type
- Biologics
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ID · c57260d9-4314-44ee-b671-13cc121450c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844699
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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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 |
| April 16, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 7, 2016 | 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 1048356 - 2018-04-16
- FDA Inspection 960804 - 2016-01-07
- FDA Inspection 794470 - 2012-08-10
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