Company
Korea (the Republic of)BONTECH CO., LTD, Suwon, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for BONTECH CO., LTD in Suwon. 1 FDA inspection on record, 1 Form 483, last inspected September 04, 2025.
Company Profile
This profile covers BONTECH CO., LTD based in Suwon, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 4, 2025.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design output - Lack of or inadequate procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1280384 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BONTECH CO., LTD
FEI Number
3013599033
Address
Digital Empire D #1201, 16, Deogyeong-Daero,1556 Beon-Gil; Yeongtong District, Suwon, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 1ef57686-3ec8-4c3c-bd34-abc7570945b3