FDA Inspection
Asahi Intecc Hanoi Co., Ltd.Asahi Intecc Hanoi Co., Ltd. – FDA Inspection, May 19, 2016
Record Details
This FDA Inspection record concerns Asahi Intecc Hanoi Co., Ltd., with an inspection on May 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Asahi Intecc Hanoi Co., Ltd.
- Inspection Date
- May 19, 2016
- Product Type
- Devices
View Company Profile
ID · d2d05141-386e-445f-a893-d0b75884109b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 976059
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.52(e)(1)Contact Office Name and Address
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Asahi Intecc Hanoi Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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