FDA Inspection
Terrebonne General Health SystemTerrebonne General Health System – FDA Inspection, Aug 6, 2012
Record Details
This FDA Inspection record concerns Terrebonne General Health System, with an inspection on August 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 6, 2012
- Product Type
- Biologics
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ID · ad4c3876-9bb6-45aa-90e5-1f1744806ae5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793595
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 610.40(h)(2)(ii)Labeling of reactive units, units from deferred donors
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terrebonne General Health System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2025 | Not classified | New Orleans District Office | |
| August 24, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 2, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Terrebonne General Health System
- FDA Inspection 1283764 - 2025-09-09
- FDA Inspection 1217492 - 2023-08-24
- FDA Inspection 1102308 - 2019-08-28
- FDA Inspection 1000028 - 2017-02-10
- FDA Inspection 928625 - 2015-06-02
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