Yokowo Co., Ltd — FDA Facility Profile

FEI 3009092139

Yokowo Co., Ltd is an FDA-registered facility (FEI 3009092139) located in Tomioka Gunma, JP. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Apr 13, 2017: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 13, 2017Voluntary Action Indicated (VAI)Design input - documentation (21 CFR 820.30(c))
Design history file (21 CFR 820.30(j))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate DHR procedures (21 CFR 820.184)
and 3 more

Facility details

Company
Yokowo Co Ltd
Location
Tomioka Gunma (JP)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.