Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-08.
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 |
|---|---|---|---|
| 5 May 2025 – 8 May 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Dec 2023 – 20 Dec 2023 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2025
21 CFR 803.50(b)(1)
Reporting Information Reasonably Known
Cited by Jesse A Vazquez, Chad E Schmear
8 May 2025
21 CFR 803.52(c)(10)
Device Available for Evaluation
Cited by Jesse A Vazquez, Chad E Schmear
8 May 2025
21 CFR 803.56
Submission of Supplement to Individual Report Within One Month
Cited by Jesse A Vazquez, Chad E Schmear
20 Dec 2023
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Dawn M Braswell, Rong Guo
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(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sol-Millennium Medical Inc.'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