FDA Inspection
RTI Surgical, Inc. dba RTI Biologics, Inc.RTI Surgical, Inc. dba RTI Biologics, Inc. – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns RTI Surgical, Inc. dba RTI Biologics, Inc., with an inspection on April 28, 2017, issued by the Florida District Office, covering biologics.
- Office
- Florida District Office
- People
- Ivan E. Reyes (Issuing Officer)
- Valerie J. Grecek-Trinh (Issuing Officer)
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ID · dcafee7d-5960-4613-9ff5-94ebb23f446a
Inspection Facts
- Inspection number
- 1012915
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Component identification test
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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