Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-31.
At a glance
Inspections
6
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jul 2025 – 31 Jul 2025 | Medical Devices & Rad Health | Clean | |
| 4 Oct 2021 – 5 Oct 2021 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2017 – 20 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 May 2015 – 10 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Feb 2013 – 11 Feb 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 15 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2017
21 CFR 820.30(g)
Design validation - production units
Cited by Melissa A Freeman, Melissa A Zuppe
Investigators
FDA investigators tied to this site in the record.
Charles Chacko2 insp.
Jonathan Ho1 insp.
William R Chang1 insp.
Matthew W Kyle1 insp.
Melissa A Freeman1 insp.
Melissa A Zuppe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Genesis BPS, LLC.'s 3 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