Company
Korea (the Republic of)Custom Tube Manufacturing LLC, Yangju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Custom Tube Manufacturing LLC in Yangju. 2 FDA inspections on record, 1 Form 483, last inspected February 16, 2023.
Company Profile
This profile covers Custom Tube Manufacturing LLC based in Yangju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 17, 2017. Last inspected February 16, 2023.
Most cited issue areas
- Procedures not adequately established or maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1197551 |
| August 17, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1026455 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Custom Tube Manufacturing LLC
FEI Number
3010966701
Address
38-4 Hyeonseokro733beon-Gil, Gwangjeok-Myeon, Yangju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: c6773157-b57b-4bca-8cf7-c82d596f149c