Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-15.
At a glance
Inspections
4
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Aug 2024 – 15 Aug 2024 | Human Drugs | 483 | View 483 → |
| 13 Apr 2022 – 21 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Mar 2018 – 8 Mar 2018 | Human Drugs | Clean | |
| 18 Nov 2014 – 8 Dec 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Apr 2022
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Brittani N Franklin
21 Apr 2022
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Brittani N Franklin
21 Apr 2022
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Brittani N Franklin
Investigators
FDA investigators tied to this site in the record.
Saundrea A Munroe1 insp.
Brittani N Franklin1 insp.
Joanne E King1 insp.
Christos G Tsingelis1 insp.
Rozelle G Smith1 insp.
Ileana Barreto-Pettit1 insp.
Richard A Lyght1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stratus Pharmaceuticals Inc's 3 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