Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-27.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 27 Jan 2023 | Human Drugs | 483 | View 483 → |
| 18 Sep 2017 – 21 Sep 2017 | Human Drugs | 483 | On file |
| 27 Oct 2014 – 31 Oct 2014 | Human Drugs | Clean | |
| 12 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jan 2023
21 CFR 211.194(a)(7)
Signatures and dates--person who performs test
Cited by Kham Phommachanh
Investigators
FDA investigators tied to this site in the record.
Kham Phommachanh1 insp.
Emily J Orban1 insp.
Truong X Nguyen1 insp.
Brant M Schroeder1 insp.
Denise R Beuttenmuller1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind KDC/ONE Development Corporation, 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