Phibro Saude Animal Internacional Ltda. FDA Record

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

Phibro Saude Animal Internacional Ltda. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Phibro Saude Animal Internacional Ltda." is on file.

What these totals cover: FDA records filed under the name "Phibro Saude Animal Internacional Ltda." and its spelling variant "Phibro Saude Animal Internacional Ltda".

Latest inspection
Jul 28, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Phibro Saude Animal Internacional Ltda.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Phibro Saude Animal Internacional Ltda.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202000000
201900000
201810000
201700000

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.

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Recent FDA inspections

4 inspections from Apr 6, 2012 to Jul 28, 2023.

DateSiteProductClassificationFEI
Jul 28, 2023Guarulhos, BrazilVeterinaryNo Action Indicated (NAI)3003286077
May 4, 2018Guarulhos, BrazilVeterinaryNo Action Indicated (NAI)3003286077
Mar 4, 2016Guarulhos, BrazilVeterinaryVoluntary Action Indicated (VAI)3003286077
Apr 6, 2012Guarulhos, BrazilVeterinaryNo Action Indicated (NAI)3003286077
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.

FacilityLocationInspectionsLatest
FEI 3003286077Guarulhos, Brazil4Jul 28, 2023

Phibro Saude Animal Internacional Ltda. and the FDA: common questions

Has Phibro Saude Animal Internacional Ltda. received an FDA warning letter?

No FDA warning letter addressed to the name "Phibro Saude Animal Internacional Ltda." 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 Phibro Saude Animal Internacional Ltda. received an FDA Form 483?

FDA has not published a Form 483 for "Phibro Saude Animal Internacional Ltda." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Phibro Saude Animal Internacional Ltda.?

The most recent FDA inspection on file ended Jul 28, 2023 at Guarulhos, Brazil and was classified NAI. FDA has 4 inspections of Phibro Saude Animal Internacional Ltda. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.