FDA Inspection
Reproductive Institute of South TexasReproductive Institute of South Texas – FDA Inspection, Jan 7, 2016
Record Details
This FDA Inspection record concerns Reproductive Institute of South Texas, with an inspection on January 7, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 7, 2016
- Product Type
- Biologics
View Company Profile
ID · 87f7b4ef-af87-4167-80fe-f46063761479
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960804
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(b)(2)Prominently labeled (limited use)
Full citation text and observation details available on the Dashboard.
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 |
| 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 1048356 - 2018-04-16
- FDA Inspection 844699 - 2013-08-16
- FDA Inspection 794470 - 2012-08-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.