Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-30.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 30 Jan 2026 | Biologics | 483 | View 483 → |
| 12 Jan 2026 – 15 Jan 2026 | Biologics | Clean | |
| 31 Jan 2023 – 7 Feb 2023 | Biologics | Clean | |
| 26 Feb 2019 – 7 Mar 2019 | Biologics | Clean | |
| 27 Nov 2018 | Biologics | Clean | |
| 13 Aug 2018 – 28 Aug 2018 | Biologics | 483 | View 483 → |
| 3 Apr 2017 – 28 Apr 2017 | Biologics | 483 | View 483 → |
| 6 Jun 2016 – 10 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 9 Sep 2013 – 10 Sep 2013 | Biologics | Clean | |
| 11 Jul 2012 | Not recorded | 483 | View 483 → |
| 25 Oct 2011 | Not recorded | 483 | View 483 → |
| 15 Oct 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jan 2026
21 CFR 1271.190(b)(1)
Clean, sanitary, orderly manner
Cited by Mizanne E Lewis, Steen N Graham
28 Aug 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gene D Arcy, Ivan E Reyes, Cody D Rickman
28 Aug 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Gene D Arcy, Ivan E Reyes, Cody D Rickman
28 Aug 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Gene D Arcy, Ivan E Reyes, Cody D Rickman
Investigators
FDA investigators tied to this site in the record.
Valerie J Grecek Trinh4 insp.
Barbara T Carmichael4 insp.
Mizanne E Lewis3 insp.
Steen N Graham2 insp.
Valerie J Grecek-Trinh2 insp.
Ivan E Reyes2 insp.
Carla A Norris2 insp.
Julie D Bringger2 insp.
Christopher J Adams1 insp.
Richard J Bashay1 insp.
Nisha C Patel1 insp.
Sarah M Forney1 insp.
Gene D Arcy1 insp.
Cody D Rickman1 insp.
Valerie J Grecek -Trinh1 insp.
Lisa A Warner1 insp.
Lura D Kelly1 insp.
Kip J Hanks1 insp.
Jana L Caylor1 insp.
Ronnie E Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.190(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RTI Surgical, Inc.'s 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat