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Yamaharu Co., Ltd. FDA Inspection Record

FEI 3004791456 · Inspections, Form 483s, warning letters and import refusals

Yamaharu Co., Ltd. is an FDA-inspected facility (FEI 3004791456) located in Koto, JP. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Nov 1, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Apr 2, 2014
Warning letters
1 listed by FDA for this FEI, latest Sep 24, 2014
Import refusals
9

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
Nov 1, 2019Voluntary Action Indicated (VAI)HACCP plan implementation (21 CFR 123.6(b))
Corrective action plan (21 CFR 123.6(c)(5))
Apr 2, 2014Official Action Indicated (OAI)Sanitation monitoring (21 CFR 123.11(b))
HACCP training or qualification (21 CFR 123.10)
No HACCP plan (21 CFR 123.6(b))

Facility details

Company
Yamaharu Co., Ltd.
Location
Koto (JP)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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