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Balfego And Balfego, SL FDA Record

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

Balfego And Balfego, SL has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Balfego And Balfego, SL, the most recent on Nov 14, 2014.

What these totals cover: FDA records filed under the name "Balfego And Balfego, SL".

Latest inspection: Aug 22, 2019 · NAI

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

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Balfego And Balfego, SL FDA Warning Letters

1 warning letter on Nov 14, 2014.

Issued	Subject	Issuing office	Close-out letter
Nov 14, 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 Apr 8, 2014 to Aug 22, 2019.

Date	Site	Product	Classification	FEI
Aug 22, 2019	L'Ametlla De Mar, Spain	Food/Cosmetics	No Action Indicated (NAI)	2000013916
Apr 8, 2014	L'Ametlla De Mar, Spain	Food/Cosmetics	Official Action Indicated (OAI)	2000013916

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 Balfego And Balfego, SL: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 14, 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 2000013916	L'Ametlla De Mar, Spain	2	Aug 22, 2019

Balfego And Balfego, SL and the FDA: common questions

Has Balfego And Balfego, SL received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Balfego And Balfego, SL. The most recent is dated Nov 14, 2014.

Has Balfego And Balfego, SL received an FDA Form 483?

FDA has not published a Form 483 for "Balfego And Balfego, SL" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Balfego And Balfego, SL?

The most recent FDA inspection on file ended Aug 22, 2019 at L'Ametlla De Mar, Spain and was classified NAI. FDA has 2 inspections of Balfego And Balfego, SL on file, 1 of them classified OAI (official action indicated).

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