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NIPPON FINE CHEMICAL CO.,LTD FDA Inspection Record

FEI 3001722961 · Inspections, Form 483s, warning letters and import refusals

NIPPON FINE CHEMICAL CO.,LTD is an FDA-registered facility (FEI 3001722961) located in HYOGO 676-0074, JP. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Nov 14, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (1 OAI, 4 VAI)
Last OAI inspection
Dec 17, 2015
Warning letters
1 listed by FDA for this FEI, latest Sep 27, 2016
Import refusals
2

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 14, 2025Voluntary Action Indicated (VAI)No citations listed
Jun 11, 2019Voluntary Action Indicated (VAI)No citations listed
Jan 31, 2017Voluntary Action Indicated (VAI)No citations listed
Dec 17, 2015Official Action Indicated (OAI)Computer control of master formula records (21 CFR 211.68(b))
Cleaning System (21 CFR 211.42(c)(10)(v))
Containers & Closures Clean, Sterilized, Pyrogen-free (21 CFR 211.94(c))
Subdivided component/container/finished drug (21 CFR 211.101(b)(4))
Jun 24, 2010Voluntary Action Indicated (VAI)No citations listed

FDA record score

9 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 14, 20256 x 16
Inspection classified VAIJun 11, 20196 x 0.251.5
Inspection classified VAIJan 31, 20176 x 0.251.5
Warning letter on FDA's dashboard, which does not show close-outsSep 27, 201610 years or older, so it adds no points0
Inspection classified OAIDec 17, 201510 years or older, so it adds no points0
Inspection classified VAIJun 24, 201010 years or older, so it adds no points0

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
Nippon Fine Chemical Co., Ltd.
Location
HYOGO 676-0074 (JP)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Compliance actions

Import refusals

FDA data resources

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