Home / Companies / Goodman Co., Ltd.

Goodman Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Goodman Co., Ltd. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Goodman Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Goodman Co., Ltd." and its spelling variant "Goodman Co".

Latest inspection: Apr 3, 2025 · NAI
Latest 510(k): Apr 22, 2025

Reviewing Goodman 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 Goodman 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

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	3	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Goodman Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

2 inspections from Jan 25, 2024 to Apr 3, 2025.

Date	Site	Product	Classification	FEI
Apr 3, 2025	Nagoya, Japan	Devices	No Action Indicated (NAI)	3007835716
Jan 25, 2024	Nagoya, Japan	Devices	Voluntary Action Indicated (VAI)	3007835716

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007835716	Nagoya, Japan	2	Apr 3, 2025

Recent 510(k) clearances

3 510(k) clearances from May 25, 2001 to Apr 22, 2025.

K-Number	Device	Date
K243944	Aperta NSE PTA Balloon Dilatation Catheter	Apr 22, 2025
K232013	Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…	Mar 28, 2024
K010763	GOODNET	May 25, 2001

Goodman Co., Ltd. and the FDA: common questions

Has Goodman Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Goodman Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Goodman Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Goodman Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Goodman Co., Ltd.?

The most recent FDA inspection on file ended Apr 3, 2025 at Nagoya, Japan and was classified NAI. FDA has 2 inspections of Goodman Co., Ltd. on file.

Need more than this page shows? Ask about Goodman Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.