Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-15.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Oct 2024 – 15 Oct 2024 | Human Drugs | 483 | On file |
| 16 Aug 2022 – 24 Aug 2022 | Human Drugs | 483 | View 483 → |
| 8 Nov 2017 – 17 Nov 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Aug 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Sonya M Edmonds
Investigators
FDA investigators tied to this site in the record.
Zhong Li1 insp.
Joao A Pedras Vasconcel1 insp.
Della Shin1 insp.
Sonya M Edmonds1 insp.
Thuy T Nguyen1 insp.
Viviana Matta1 insp.
Alicia M Mozzachio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Daewoong Pharmaceutical Co. Ltd.'s 3 Form 483s
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