Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-12.
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 |
|---|---|---|---|
| 9 Jun 2026 – 12 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2024 – 10 Jul 2024 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2026
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Scott D Stevens, Jae H Lee
12 Jun 2026
21 CFR 820.35(a)
Records for complaints involving failure to meet specifications not maintained
Cited by Scott D Stevens, Jae H Lee
12 Jun 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Scott D Stevens, Jae H Lee
12 Jun 2026
ISO 13485:2016 Clause 4.1.5
Inadequate monitoring and control over outsourced processes
Cited by Scott D Stevens, Jae H Lee
12 Jun 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by Scott D Stevens, Jae H Lee
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MODERN MEDICAL SUPPLIES 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