CORENTEC CO., LTD. FDA Inspection Record
CORENTEC CO., LTD. is an FDA-registered facility (FEI 3009106092) located in Cheonan Si, Chungnam, KR. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Aug 29, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (4 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 Mar 29, 2024
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 29, 2024 | Voluntary Action Indicated (VAI) | Software validation for automated processes (21 CFR 820.70(i)) |
| Oct 31, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 9, 2015 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) DHR content (21 CFR 820.184) Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1)) and 3 more |
| Jan 16, 2014 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Procedures not adequately established or maintained (21 CFR 820.40) Design review - Lack of or inadequate procedures (21 CFR 820.30(e)) Lack of or inadequate procedures for labeling (21 CFR 820.120) and 3 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 29, 2024 | Class II | Z-1934-2024 | LOSPA Tibial Insert
Model/Catalog Number: See below
Software Version: N/A
Product… and 1 more product Due to unsupported 10 year expiration date. |
| Feb 27, 2017 | Class II | Z-1454-2017 | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. |
FDA record score
9 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.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Aug 29, 2024 | 6 x 0.6 | 3.6 |
| Class II recall Z-1934-2024, this FEI as the recalling firm | Mar 29, 2024 | 4 x 0.6 | 2.4 |
| Inspection classified VAI | Oct 31, 2019 | 6 x 0.25 | 1.5 |
| Class II recall Z-1454-2017, this FEI as the recalling firm | Feb 27, 2017 | 4 x 0.25 | 1 |
| Inspection classified VAI | Apr 9, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jan 16, 2014 | 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
- Corentec Co., LTD
- Location
- Cheonan Si, Chungnam (KR)
- Source
- device