Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-18.
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 |
|---|---|---|---|
| 10 Oct 2022 – 18 Oct 2022 | Human Drugs | 483 | View 483 → |
| 7 Oct 2019 – 15 Oct 2019 | Human Drugs | 483 | View 483 → |
| 10 Sep 2018 – 18 Sep 2018 | Human Drugs | 483 | On file |
| 7 Nov 2016 – 15 Nov 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Veronica Fuentes, David J Gomes
15 Oct 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Yvins Dezan, Philip F Istafanos
15 Oct 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Yvins Dezan, Philip F Istafanos
15 Oct 2019
21 CFR 211.160(b)(1)
Sampling and testing procedures described
Cited by Yvins Dezan, Philip F Istafanos
Investigators
FDA investigators tied to this site in the record.
Veronica Fuentes1 insp.
David J Gomes1 insp.
Yvins Dezan1 insp.
Philip F Istafanos1 insp.
Dennis Cantellops Paite1 insp.
Diane Goll1 insp.
Lucas B Leake1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Taejoon Pharmaceutical 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