Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-10.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2026 – 10 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Oct 2022 – 24 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Javonica F Penn
10 Mar 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Javonica F Penn
10 Mar 2026
ISO 13485:2016 Clause 5.1
Lack of evidence for top management's commitment to QMS
Cited by Javonica F Penn
Investigators
FDA investigators tied to this site in the record.
Javonica F Penn2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| ISO 13485:2016 Clause 4.1.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 5.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 6.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind WORLD SOURCE SIMPLE LLC'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