FDA Inspection
Yokowo Co LtdYokowo Co Ltd – FDA Inspection, Apr 13, 2017
Record Details
This FDA Inspection record concerns Yokowo Co Ltd, with an inspection on April 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f85557ec-d962-4780-8021-13d92df71a70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015641
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(f)Design verification - documentation
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