FDA Inspection
RTI Surgical, Inc. dba RTI Biologics, Inc.RTI Surgical, Inc. dba RTI Biologics, Inc. – FDA Inspection, Jul 11, 2012
Record Details
This FDA Inspection record concerns RTI Surgical, Inc. dba RTI Biologics, Inc., with an inspection on July 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 11, 2012
- Product Type
- Biologics
View Company Profile
ID · 2fcf3be7-a077-41f0-bb8c-6852f73c32ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 789181
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.195(b)Corrective actions
- 21 CFR 1271.160(b)(3)Actions verified, short and long term solutions
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.195(a)(1)Temperature and humidity controls
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.160(b)(5)Monitoring systems
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
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.