Nartex Laboratorios Homeopaticos S.A. De C.V. FDA Record

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

  • Latest inspection VAI · Dec 15, 2023
  • Last warning letter 2020
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Nov 4, 2020
510(k) clearances 0 None on file

Nartex Laboratorios Homeopaticos S.A. De C.V. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Nartex Laboratorios Homeopaticos S.A. De C.V., the most recent on Nov 4, 2020.

What these totals cover: FDA records filed under the name "Nartex Laboratorios Homeopaticos S.A. De C.V." and its spelling variant "Nartex Laboratorios Homeopaticos S.A. De C.V".

Latest inspection
Dec 15, 2023 · VAI

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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Nartex Laboratorios Homeopaticos S.A. De C.V.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Nartex Laboratorios Homeopaticos S.A. De C.V.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202011100
201900000
201800000
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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Nartex Laboratorios Homeopaticos S.A. De C.V. FDA Warning Letters

1 warning letter on Nov 4, 2020.

IssuedSubjectIssuing officeClose-out letter
Nov 4, 2020 · Letter on fda.gov Center for Drug Evaluation and Research | CDER

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 Feb 28, 2020 to Dec 15, 2023.

DateSiteProductClassificationFEI
Dec 15, 2023Torreon, MexicoDrugsVoluntary Action Indicated (VAI)3009407408
Feb 28, 2020Torreon, MexicoDrugsOfficial Action Indicated (OAI)3009407408
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 Nartex Laboratorios Homeopaticos S.A. De C.V.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 4, 2020.

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.

FacilityLocationInspectionsLatest
FEI 3009407408Torreon, Mexico2Dec 15, 2023

Nartex Laboratorios Homeopaticos S.A. De C.V. and the FDA: common questions

Has Nartex Laboratorios Homeopaticos S.A. De C.V. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Nartex Laboratorios Homeopaticos S.A. De C.V.. The most recent is dated Nov 4, 2020.

Has Nartex Laboratorios Homeopaticos S.A. De C.V. received an FDA Form 483?

FDA has not published a Form 483 for "Nartex Laboratorios Homeopaticos S.A. De C.V." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Nartex Laboratorios Homeopaticos S.A. De C.V.?

The most recent FDA inspection on file ended Dec 15, 2023 at Torreon, Mexico and was classified VAI. FDA has 2 inspections of Nartex Laboratorios Homeopaticos S.A. De C.V. on file, 1 of them classified OAI (official action indicated).

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