FDA Inspection
OEM Systems Co. Ltd.OEM Systems Co. Ltd. – FDA Inspection, Oct 28, 2010
Record Details
This FDA Inspection record concerns OEM Systems Co. Ltd., with an inspection on October 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OEM Systems Co. Ltd.
- Inspection Date
- October 28, 2010
- Product Type
- Devices
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ID · 4450a37c-5643-48d9-aa24-b4a53a1af41c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 699130
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of OEM Systems Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 26, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OEM Systems Co. Ltd.
- FDA Inspection 1198268 - 2023-01-27
- FDA Inspection 897530 - 2014-09-26
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