Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-03.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2025 – 3 Dec 2025 | Human Drugs | 483 | View 483 → |
| 6 Jun 2022 – 9 Jun 2022 | Human Drugs | Clean | |
| 22 Jan 2019 – 25 Jan 2019 | Foods & Cosmetics | Clean | |
| 8 Dec 2015 – 11 Dec 2015 | Human Drugs | 483 | View 483 → |
| 28 Apr 2011 | Not recorded | Clean | |
| 21 May 2010 | Not recorded | Clean | |
| 11 Mar 2008 | Not recorded | 483 | On file |
| 15 Jul 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2015
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Vilmary Negron Rodriguez, Doan T Nguyen
11 Dec 2015
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Vilmary Negron Rodriguez, Doan T Nguyen
11 Dec 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vilmary Negron Rodriguez, Doan T Nguyen
Investigators
FDA investigators tied to this site in the record.
Timothy T Kapsala3 insp.
Mickell Smith1 insp.
Michael Araneta1 insp.
Gavin T Cua1 insp.
Matthew A Johnson1 insp.
Vilmary Negron Rodriguez1 insp.
Doan T Nguyen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kingdomway Health Sciences 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