Sumitomo Chemical Company, Limited — FDA Facility Profile

FEI 3002808125

Sumitomo Chemical Company, Limited is an FDA-registered facility (FEI 3002808125) located in Gifu 503-0125, JP. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Oct 31, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 5 VAI, 1 NAI)
Last OAI inspection
Apr 9, 2009
Warning letters
1 listed by FDA for this FEI, latest Aug 24, 2009

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
Oct 31, 2025Voluntary Action Indicated (VAI)No citations listed
Sep 6, 2019Voluntary Action Indicated (VAI)No citations listed
Dec 8, 2017Voluntary Action Indicated (VAI)No citations listed
Sep 23, 2016Voluntary Action Indicated (VAI)No citations listed
Mar 14, 2014No Action Indicated (NAI)No citations listed
Jun 18, 2010Voluntary Action Indicated (VAI)No citations listed
Apr 9, 2009Official Action Indicated (OAI)No citations listed

Facility details

Company
Sumitomo Chemical Co., Ltd.
Location
Gifu 503-0125 (JP)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

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