FDA Inspection
Omron (Dalian) Co., Ltd. (Plant 1)Omron (Dalian) Co., Ltd. (Plant 1) – FDA Inspection, Oct 20, 2011
Record Details
This FDA Inspection record concerns Omron (Dalian) Co., Ltd. (Plant 1), with an inspection on October 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 20, 2011
- Product Type
- Devices
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ID · 9c046bfd-4fdc-4b94-95f7-dc273800542b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 752079
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Omron (Dalian) Co., Ltd. (Plant 1)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Omron (Dalian) Co., Ltd. (Plant 1)
- FDA Inspection 1005604 - 2017-02-23
- FDA Inspection 562050 - 2009-01-21
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