NIPRO CORPORATION ODATE FACTORY — FDA Facility Profile

FEI 3002807710

NIPRO CORPORATION ODATE FACTORY is an FDA-registered facility (FEI 3002807710) located in ODATE-SHI Akita, JP. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 24, 2024: No Action Indicated (NAI)
Inspections on record
5 (1 OAI, 2 VAI, 2 NAI)
Last OAI inspection
Oct 29, 2009
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
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
Apr 24, 2024No Action Indicated (NAI)No citations listed
Jul 5, 2018Voluntary Action Indicated (VAI)Lack of or inadequate process validation (21 CFR 820.75(a))
Apr 16, 2015Voluntary Action Indicated (VAI)No citations listed
Sep 29, 2011No Action Indicated (NAI)No citations listed
Oct 29, 2009Official Action Indicated (OAI)No citations listed

Facility details

Company
NIPRO CORP.
Location
ODATE-SHI Akita (JP)
Source
device

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