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TERUMO YAMAGUCHI CORPORATION — FDA Facility Profile

FEI 3013611763

TERUMO YAMAGUCHI CORPORATION is an FDA-registered facility (FEI 3013611763) located in Yamaguchi-shi, JP. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 30, 2023: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
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
Form 483 and inspection documents
1 in FDA's reading room

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
Mar 30, 2023Voluntary Action Indicated (VAI)Representative Samples (21 CFR 211.84(b))
Backup data not assured as exact and complete (21 CFR 211.68(b))
Feb 19, 2020No Action Indicated (NAI)No citations listed

Form 483s and inspection documents

Facility details

Company
TERUMO YAMAGUCHI CORPORATION
Location
Yamaguchi-shi (JP)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
both

FDA data resources

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