Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-19.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 19 May 2026 | Human Drugs | 483 | View 483 → |
| 20 Oct 2022 – 27 Oct 2022 | Human Drugs | 483 | View 483 → |
| 17 Oct 2019 – 25 Oct 2019 | Human Drugs | WL | View 483 → |
| 4 Sep 2017 – 8 Sep 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Khoa Nathan V Tran, Damaris Y Hernandez
19 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Khoa Nathan V Tran, Damaris Y Hernandez
19 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Khoa Nathan V Tran, Damaris Y Hernandez
19 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Khoa Nathan V Tran, Damaris Y Hernandez
19 May 2026
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Khoa Nathan V Tran, Damaris Y Hernandez
Investigators
FDA investigators tied to this site in the record.
Khoa Nathan V Tran1 insp.
Damaris Y Hernandez1 insp.
Veronica Fuentes1 insp.
David J Gomes1 insp.
Yvins Dezan1 insp.
Philip F Istafanos1 insp.
Constance Y Fears1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Samchundang Pharm Co., Ltd.'s 4 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