FDA Inspection
RTI Surgical, Inc. dba RTI Biologics, Inc.RTI Surgical, Inc. dba RTI Biologics, Inc. – FDA Inspection, Oct 25, 2011
Record Details
This FDA Inspection record concerns RTI Surgical, Inc. dba RTI Biologics, Inc., with an inspection on October 25, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 25, 2011
- Product Type
- Biologics
View Company Profile
ID · 36fcc185-c03d-4e7e-b194-a4dea28627d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749831
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.230(a)Validation & approval--established procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RTI Surgical, Inc. dba RTI Biologics, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2026 | Not classified | Florida District Office | Human Cellular, Tissue, and Gene Therapies |
| February 7, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 7, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 27, 2018 | Not classified | Florida District Office | |
| August 28, 2018 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for RTI Surgical, Inc. dba RTI Biologics, Inc.
- FDA Inspection 1284376 - 2026-01-30
- FDA Inspection 1198983 - 2023-02-07
- FDA Inspection 1084437 - 2019-03-07
- FDA Inspection 1077164 - 2018-11-27
- FDA Inspection 1063577 - 2018-08-28
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