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C-Axis Inc. FDA Record

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

C-Axis Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "C-Axis Inc." is on file.

What these totals cover: FDA records filed under the name "C-Axis Inc." and its spelling variant "C-Axis".

Latest inspection: Apr 30, 2025 · NAI

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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	0	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

Recent FDA inspections

2 inspections from Sep 21, 2011 to Apr 30, 2025.

Date	Site	Product	Classification	FEI
Apr 30, 2025	Hamel, MN	Devices	No Action Indicated (NAI)	3004016606
Sep 21, 2011	Hamel, MN	Devices	No Action Indicated (NAI)	3004016606

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 3004016606	Hamel, MN	2	Apr 30, 2025

C-Axis Inc. and the FDA: common questions

Has C-Axis Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "C-Axis Inc." 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 C-Axis Inc. received an FDA Form 483?

FDA has not published a Form 483 for "C-Axis Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect C-Axis Inc.?

The most recent FDA inspection on file ended Apr 30, 2025 at Hamel, MN and was classified NAI. FDA has 2 inspections of C-Axis Inc. on file.

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