Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-15.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2024 | Foods & Cosmetics | 483 | View 483 → |
| 14 Oct 2020 – 28 Oct 2020 | Foods & Cosmetics | Clean | |
| 27 Mar 2018 – 3 Apr 2018 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2018
21 CFR 1.505(d)
Evaluation, reevaluation - another entity
Cited by Feryal Ahmad, Joseph Duca
Investigators
FDA investigators tied to this site in the record.
Willy A Orantes1 insp.
Coleburn E Vielehr1 insp.
Seemay A Lee1 insp.
Feryal Ahmad1 insp.
Joseph Duca1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.502(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Source One International's 2 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