Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-21.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2026 – 21 Apr 2026 | Human Drugs | 483 | View 483 → |
| 9 Jan 2019 – 15 Jan 2019 | Human Drugs | 483 | View 483 → |
| 24 May 2016 – 27 May 2016 | Human Drugs | 483 | On file |
| 16 Oct 2013 – 22 Oct 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jan 2019
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Patty P Kaewussdangkul
15 Jan 2019
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Patty P Kaewussdangkul
Investigators
FDA investigators tied to this site in the record.
Youkeun Kim1 insp.
Patty P Kaewussdangkul1 insp.
Scott T Ballard1 insp.
Hala L Selby1 insp.
Patrice S Hall1 insp.
Stephen D Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.60(g)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SOFIE Co. dba SOFIE's 4 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