FDA Inspection
Tri-State Biologics Inc.Tri-State Biologics Inc. – FDA Inspection, Jan 7, 2014
Record Details
This FDA Inspection record concerns Tri-State Biologics Inc., with an inspection on January 7, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Tri-State Biologics Inc.
- Inspection Date
- January 7, 2014
- Product Type
- Biologics
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ID · a08d2c7d-05cd-4f6a-b561-ff5fac601db0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 861316
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.290(d)Recording I.D. code and type of HCT/P
- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.260(e)Periodic review of temperatures
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Other FDA inspections of Tri-State Biologics Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 18, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 19, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Tri-State Biologics Inc.
- FDA Inspection 1237963 - 2024-04-29
- FDA Inspection 1097263 - 2019-07-18
- FDA Inspection 939326 - 2015-08-19
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