DEXCOWIN CO., LTD. FDA Inspection Record
DEXCOWIN CO., LTD. is an FDA-registered facility (FEI 3007065358) located in Seoul, KR. RegDataLab tracks 5 FDA inspections and 2 compliance actions at this facility.
What FDA found at this site
- Latest inspection
- Feb 23, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 2 listed by FDA for this FEI, latest Feb 20, 2018
- Form 483 and inspection documents
- 1 in FDA's reading room
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 23, 2023 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
| Jun 6, 2019 | No Action Indicated (NAI) | No citations listed |
| Aug 31, 2017 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design verification - output does not meet input requirement (21 CFR 820.30(f)) Procedures not adequately established or maintained (21 CFR 820.40) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) and 12 more |
| Mar 26, 2015 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design verification - output does not meet input requirement (21 CFR 820.30(f)) Design input - documentation (21 CFR 820.30(c)) Lack of or inadequate DHR procedures (21 CFR 820.184) and 4 more |
| Jun 3, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
Form 483s and inspection documents
FDA record score
13 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Warning letter on FDA's dashboard, which does not show close-outs | Feb 20, 2018 | 30 x 0.25 | 7.5 |
| Inspection classified VAI | Feb 23, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Aug 31, 2017 | 6 x 0.25 | 1.5 |
| Warning letter on FDA's dashboard, which does not show close-outs | Aug 15, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jun 3, 2011 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Dexcowin Co. Ltd.
- Location
- Seoul (KR)
- Source
- device