Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-11.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jul 2023 – 11 Aug 2023 | Human Drugs | 483 | View 483 → |
| 26 Jun 2017 – 28 Jun 2017 | Human Drugs | Clean | |
| 12 May 2015 – 15 May 2015 | Human Drugs | 483 | On file |
| 27 Sep 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Aug 2023
21 CFR 212.30(a)
Orderly handling, prevention of mix-ups, prevention of contamination
Cited by Tamil Arasu, Rose L Jean-Mary
11 Aug 2023
21 CFR 212.71(b)
Documentation of Non-Conforming Product Investigation
Cited by Tamil Arasu, Rose L Jean-Mary
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Rose L Jean-Mary1 insp.
Paul L Bellamy1 insp.
Michael R Klapal1 insp.
Douglas C Kovacs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(b) | 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 2 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