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NATURA BISSE INTERNATIONAL SA FDA Record

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

NATURA BISSE INTERNATIONAL SA has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to NATURA BISSE INTERNATIONAL SA, the most recent on Dec 15, 2016.

What these totals cover: FDA records filed under the name "NATURA BISSE INTERNATIONAL SA" and its spelling variant "Natura Bisse International".

Latest inspection: Sep 16, 2022 · VAI

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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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NATURA BISSE INTERNATIONAL SA FDA Warning Letters

1 warning letter on Dec 15, 2016.

Issued	Subject	Issuing office	Close-out letter
Dec 15, 2016 · Record page

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

3 inspections from Feb 15, 2013 to Sep 16, 2022.

Date	Site	Product	Classification	FEI
Sep 16, 2022	Cerdanyola Del Valles, Spain	Drugs	Voluntary Action Indicated (VAI)	3008301076
Jan 29, 2016	Cerdanyola Del Valles, Spain	Drugs	Official Action Indicated (OAI)	3008301076
Feb 15, 2013	Cerdanyola Del Valles, Spain	Drugs	Voluntary Action Indicated (VAI)	3008301076

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 NATURA BISSE INTERNATIONAL SA: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 15, 2016.

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 3008301076	Cerdanyola Del Valles, Spain	3	Sep 16, 2022

NATURA BISSE INTERNATIONAL SA and the FDA: common questions

Has NATURA BISSE INTERNATIONAL SA received an FDA warning letter?

Yes. FDA has issued 1 warning letter to NATURA BISSE INTERNATIONAL SA. The most recent is dated Dec 15, 2016.

Has NATURA BISSE INTERNATIONAL SA received an FDA Form 483?

FDA has not published a Form 483 for "NATURA BISSE INTERNATIONAL SA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect NATURA BISSE INTERNATIONAL SA?

The most recent FDA inspection on file ended Sep 16, 2022 at Cerdanyola Del Valles, Spain and was classified VAI. FDA has 3 inspections of NATURA BISSE INTERNATIONAL SA on file, 1 of them classified OAI (official action indicated).

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