FDA Inspection
Reproductive Institute of South TexasReproductive Institute of South Texas – FDA Inspection, Aug 10, 2012
Record Details
This FDA Inspection record concerns Reproductive Institute of South Texas, with an inspection on August 10, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 10, 2012
- Product Type
- Biologics
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ID · 69759104-e296-44cb-b27e-3c08497fb65f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 794470
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.47(c)Availability of procedures
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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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 16, 2013 | VAI | 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 844699 - 2013-08-16
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