Company
Korea (the Republic of)UNILAM CO., LTD, Ulju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for UNILAM CO., LTD in Ulju. 2 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected December 08, 2022.
Company Profile
This profile covers UNILAM CO., LTD based in Ulju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected June 30, 2017. Last inspected December 8, 2022.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR content1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1192582 |
| June 30, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1019783 |
FDA documents
Warning Letters (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
UNILAM CO., LTD
FEI Number
3007123863
Address
23 Samdong-Ro, Samnam-Myeon, Ulju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: a08222c3-3b0f-4e0f-9265-056b4cf5e22e