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SAGAMI RUBBER INDUSTRIES CO., LTD. FDA Inspection Record

FEI 3002808077 · Inspections, Form 483s, warning letters and import refusals

SAGAMI RUBBER INDUSTRIES CO., LTD. is an FDA-registered facility (FEI 3002808077) located in ATSUGI-SHI Kanagawa, JP. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jul 24, 2015: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Nov 24, 2015
Import refusals
10 or more

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
Jul 24, 2015Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Procedures not adequately established or maintained (21 CFR 820.40)
Lack of or inadequate procedures (21 CFR 820.100(a))
Investigation of device failures (21 CFR 820.198(c))
and 3 more
Feb 4, 2011Voluntary Action Indicated (VAI)Lack of or inadequate final acceptance procedures (21 CFR 820.80(d))
Documentation (21 CFR 820.80(e))
Lack of or inadequate DHR procedures (21 CFR 820.184)
Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1))
and 1 more

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Sagami Rubber Industries Co., Ltd.
Location
ATSUGI-SHI Kanagawa (JP)
Source
device

Compliance actions

Import refusals

FDA data resources

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