FDA Inspection
Sooil Development Co., Ltd.Sooil Development Co., Ltd. – FDA Inspection, Jan 23, 2020
Record Details
This FDA Inspection record concerns Sooil Development Co., Ltd., with an inspection on January 23, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sooil Development Co., Ltd.
- Inspection Date
- January 23, 2020
- Product Type
- Devices
View Company Profile
ID · d3bf3970-46e0-4c32-b80f-2e8a73fbfc3d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1116210
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Enforcement
- Warning Letter
FDA Citations
8- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sooil Development Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2008 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sooil Development Co., Ltd.
- FDA Inspection 732961 - 2011-07-06
- FDA Inspection 547154 - 2008-11-06
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