Wonjin Mulsan Co., Ltd. FDA Inspection Record
Wonjin Mulsan Co., Ltd. is an FDA-inspected facility (FEI 3006797972) located in Seo. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Oct 22, 2015: Official Action Indicated (OAI)
- Inspections on record
- 2 (2 OAI)
- Last OAI inspection
- Oct 22, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Jul 31, 2013
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 22, 2015 | Official Action Indicated (OAI) | No citations listed |
| Apr 4, 2013 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 1 more |
FDA record score
0 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.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified OAI | Oct 22, 2015 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Jul 31, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Apr 4, 2013 | 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
- Wonjin Mulsan Co., Ltd.
- Location
- Seo
- Source
- inspections