FDA Inspection
Tsubasa Industry Co., Ltd.Tsubasa Industry Co., Ltd. – FDA Inspection, Jul 25, 2019
Record Details
This FDA Inspection record concerns Tsubasa Industry Co., Ltd., with an inspection on July 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · a79f6d93-6df5-48ec-b46c-aa8d9993da6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Tsubasa Industry Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tsubasa Industry Co., Ltd.
- FDA Inspection 850596 - 2013-09-12
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