Home / Facilities / 3002807522

MACHIDA ENDOSCOPE CO., LTD. FDA Inspection Record

FEI 3002807522 · Inspections, Form 483s, warning letters and import refusals

MACHIDA ENDOSCOPE CO., LTD. is an FDA-registered facility (FEI 3002807522) located in Abiko Chiba, JP. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
May 28, 2026: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 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
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
May 28, 2026Voluntary Action Indicated (VAI)Design and development validation not complete prior to release of product (ISO 13485:2016 Clause 7.3.7)
Procedures for validation of processes lack required elements (ISO 13485:2016 Clause 7.5.6)
Procedures for monitoring and measuring equipment requirements not documented (ISO 13485:2016 Clause 7.6)
Dec 7, 2023Voluntary Action Indicated (VAI)Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1))
Aug 23, 2017No Action Indicated (NAI)No citations listed

FDA record score

10 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 15, 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.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 28, 20266 x 16
Inspection classified VAIDec 7, 20236 x 0.63.6

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

Reviewing MACHIDA ENDOSCOPE CO., LTD. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check MACHIDA ENDOSCOPE CO., LTD. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Machida Endoscope Co., Ltd.
Location
Abiko Chiba (JP)
Source
device

Import refusals

FDA data resources

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