Company
Korea (the Republic of)Sooil Development Co., Ltd., Yongin, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Sooil Development Co., Ltd. in Yongin. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected January 23, 2020.
Company Profile
This profile covers Sooil Development Co., Ltd. based in Yongin, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected November 6, 2008. Last inspected January 23, 2020.
Most cited issue areas
- Calibration procedures - content1 inspection
- Documentation1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2020 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1116210 |
| July 6, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 732961 |
| November 6, 2008 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 547154 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sooil Development Co., Ltd.
FEI Number
3003024060
Address
Giheung, 62 Yonggu-Daero 2325 Beon-Gil, Yongin, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 143e4065-e074-4301-b860-2b20304c5678