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Cotton High Tech S.L.( D/Ba COHITECH) FDA Record

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

Cotton High Tech S.L.( D/Ba COHITECH) has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Cotton High Tech S.L.( D/Ba COHITECH), the most recent on Jan 23, 2014.

What these totals cover: FDA records filed under the name "Cotton High Tech S.L.( D/Ba COHITECH)".

Latest inspection: Feb 20, 2015 · VAI

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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	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Cotton High Tech S.L.( D/Ba COHITECH) FDA Warning Letters

1 warning letter on Jan 23, 2014.

Issued	Subject	Issuing office	Close-out letter
Jan 23, 2014

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Aug 8, 2013 to Feb 20, 2015.

Date	Site	Product	Classification	FEI
Feb 20, 2015	Balsareny, Spain	Devices	Voluntary Action Indicated (VAI)	3006517653
Aug 8, 2013	Balsareny, Spain	Devices	Official Action Indicated (OAI)	3006517653

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Cotton High Tech S.L.( D/Ba COHITECH): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 23, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006517653	Balsareny, Spain	2	Feb 20, 2015

Cotton High Tech S.L.( D/Ba COHITECH) and the FDA: common questions

Has Cotton High Tech S.L.( D/Ba COHITECH) received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Cotton High Tech S.L.( D/Ba COHITECH). The most recent is dated Jan 23, 2014.

Has Cotton High Tech S.L.( D/Ba COHITECH) received an FDA Form 483?

FDA has not published a Form 483 for "Cotton High Tech S.L.( D/Ba COHITECH)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Cotton High Tech S.L.( D/Ba COHITECH)?

The most recent FDA inspection on file ended Feb 20, 2015 at Balsareny, Spain and was classified VAI. FDA has 2 inspections of Cotton High Tech S.L.( D/Ba COHITECH) on file, 1 of them classified OAI (official action indicated).

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