Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-25.
At a glance
Inspections
12
Form 483s
7
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2024 – 25 Apr 2024 | Human Drugs | 483 | On file |
| 13 Jun 2022 – 21 Jun 2022 | Human Drugs | 483 | On file |
| 14 Oct 2019 – 22 Oct 2019 | Human Drugs | 483 | On file |
| 9 Sep 2019 – 12 Sep 2019 | Human Drugs | 483 | View 483 → |
| 16 Jul 2018 – 27 Jul 2018 | Human Drugs | 483 | On file |
| 14 Nov 2016 – 24 Nov 2016 | Human Drugs | 483 | On file |
| 1 May 2014 – 8 May 2014 | Human Drugs | Clean | |
| 12 Aug 2013 – 16 Aug 2013 | Human Drugs | Clean | |
| 30 Apr 2012 | Not recorded | 483 | On file |
| 5 Feb 2010 | Not recorded | Clean | |
| 28 Mar 2002 | Not recorded | Clean | |
| 8 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Robert J Ham1 insp.
Dongping Dai1 insp.
Teresa I Navas1 insp.
Bijoy Panicker1 insp.
Samina S Khan1 insp.
Nicole E Knowlton1 insp.
Santos E Camara1 insp.
Arsen Karapetyan1 insp.
Cody D Rickman1 insp.
Michael R Goga1 insp.
Patric C Klotzbuecher1 insp.
Jose R Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind YUNG SHIN PHARM. IND. CO., LTD.'s 7 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