CG MedTech Co., Ltd. FDA Inspection Record
CG MedTech Co., Ltd. is an FDA-registered facility (FEI 3003200961) located in Uijeongbu-si Gyeonggi, KR. RegDataLab tracks 3 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Jun 15, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest May 26, 2020
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 15, 2023 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design control - no procedures (21 CFR 820.30(a)) Contamination control, Lack of or inadequate procedures (21 CFR 820.70(e)) Justification for not reporting (21 CFR 806.20(b)(4)) |
| Nov 14, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 5, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 26, 2020 | Class II | Z-2672-2020 | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM 6.0x50mm poly-reduction screws were laser etched 6.0x45 |
| Jan 30, 2019 | Class II | Z-1823-2020 | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407… The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists… |
FDA record score
7 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 |
|---|---|---|---|
| Inspection classified VAI | Jun 15, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Nov 14, 2019 | 6 x 0.25 | 1.5 |
| Class II recall Z-2672-2020, this FEI as the recalling firm | May 26, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-1823-2020, this FEI as the recalling firm | Jan 30, 2019 | 4 x 0.25 | 1 |
| Inspection classified VAI | Feb 5, 2015 | 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 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 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 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- CG MedTech Co., Ltd.
- Location
- Uijeongbu-si Gyeonggi (KR)
- Source
- device