MBB Production Mexico S. De R.L. De C.V. FDA Record

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

  • Latest inspection OAI · Sep 29, 2022
  • Last warning letter 2019
Inspections 1 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Dec 13, 2019
510(k) clearances 0 None on file

MBB Production Mexico S. De R.L. De C.V. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to MBB Production Mexico S. De R.L. De C.V., the most recent on Dec 13, 2019.

What these totals cover: FDA records filed under the name "MBB Production Mexico S. De R.L. De C.V." and its spelling variant "Mbb Production Mexico S. De R.L. De C.V".

Latest inspection
Sep 29, 2022 · OAI

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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

MBB Production Mexico S. De R.L. De C.V.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

MBB Production Mexico S. De R.L. De C.V.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202211000
202100000
202000000
201900100
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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MBB Production Mexico S. De R.L. De C.V. FDA Warning Letters

1 warning letter on Dec 13, 2019.

IssuedSubjectIssuing officeClose-out letter
Dec 13, 2019 · 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

1 inspection on Sep 29, 2022.

DateSiteProductClassificationFEI
Sep 29, 2022Tijuana, MexicoDrugsOfficial Action Indicated (OAI)3012285699
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 MBB Production Mexico S. De R.L. De C.V.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 13, 2019.

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 3012285699Tijuana, Mexico1Sep 29, 2022

MBB Production Mexico S. De R.L. De C.V. and the FDA: common questions

Has MBB Production Mexico S. De R.L. De C.V. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to MBB Production Mexico S. De R.L. De C.V.. The most recent is dated Dec 13, 2019.

Has MBB Production Mexico S. De R.L. De C.V. received an FDA Form 483?

FDA has not published a Form 483 for "MBB Production Mexico S. De R.L. De C.V." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect MBB Production Mexico S. De R.L. De C.V.?

The most recent FDA inspection on file ended Sep 29, 2022 at Tijuana, Mexico and was classified OAI. FDA has 1 inspection of MBB Production Mexico S. De R.L. 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.