Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-11.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2024 – 11 Jun 2024 | Biologics | 483 | View 483 → |
| 26 Oct 2021 – 10 Nov 2021 | Biologics | 483 | View 483 → |
| 6 Feb 2019 – 28 Feb 2019 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2024
21 CFR 1271.230(a)
Process validation procedures
Cited by Richard T Riggie, Ramon L Gonzalez-Prieto
10 Nov 2021
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
10 Nov 2021
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
10 Nov 2021
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
Investigators
FDA investigators tied to this site in the record.
Richard T Riggie1 insp.
Ramon L Gonzalez-Prieto1 insp.
Abby L Mozeke-Baker1 insp.
Decarlos A Gomez1 insp.
Elmina E Akwo1 insp.
Aneel K Sandhu1 insp.
Lauren M Lilly1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.190(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.230(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.260(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.260(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.265(c)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.265(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.85(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Stratus BioSystems, LLC's 3 Form 483s
Source PDFs 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