Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-22.
At a glance
Inspections
4
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jan 2024 – 22 Jan 2024 | Human Drugs | 483 | View 483 → |
| 13 Sep 2021 – 22 Sep 2021 | Human Drugs | 483 | View 483 → |
| 3 Apr 2019 – 12 Apr 2019 | Human Drugs | WL | View 483 → |
| 30 Jul 2014 – 5 Aug 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jan 2024
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Jessica P Mcalister
22 Sep 2021
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Saundrea A Munroe, Nakesha J Jackson
Investigators
FDA investigators tied to this site in the record.
Saundrea A Munroe2 insp.
Jessica P Mcalister1 insp.
Nakesha J Jackson1 insp.
Jessica L Pressley1 insp.
Angela E Glenn1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 212.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(f)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.80(d) | 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