Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-01-15.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 15 Jan 2026 | Human Drugs | 483 | View 483 → |
| 15 Aug 2016 – 17 Aug 2016 | Human Drugs | Clean | |
| 2 Dec 2014 – 5 Dec 2014 | Human Drugs | Clean | |
| 24 Oct 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jan 2026
21 CFR 212.20(d)
Determination need for investigation
Cited by Monica E Murie, Shannon L Maisano
Investigators
FDA investigators tied to this site in the record.
Monica E Murie1 insp.
Shannon L Maisano1 insp.
Brian D Nicholson1 insp.
Russell K Riley1 insp.
Christopher D Leach1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sofie Co.'s 1 Form 483
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