BOEHRINGER INGELHEIM PROMECO S.A. De C.V. FDA Record

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

  • Latest inspection VAI · Feb 9, 2024
  • No warning letters matched by name
Inspections 7 1 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

BOEHRINGER INGELHEIM PROMECO S.A. De C.V. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BOEHRINGER INGELHEIM PROMECO S.A. De C.V." is on file.

What these totals cover: FDA records filed under the name "BOEHRINGER INGELHEIM PROMECO S.A. De C.V." and its spelling variant "Boehringer Ingelheim Promeco S.A. De C.V". Records filed under related names are not included; see Related names.

Latest recall
D-0657-2026 · Jun 12, 2026 · filed under Boehringer Ingelheim Pharmaceuticals
Latest inspection
Feb 9, 2024 · VAI

Newer recall under related name Boehringer Ingelheim Pharmaceuticals: Jun 12, 2026, D-0657-2026.

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
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

BOEHRINGER INGELHEIM PROMECO 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).

BOEHRINGER INGELHEIM PROMECO S.A. De C.V.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202210000
202100000
202000000
201911000
201800000
201710000

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

7 inspections from Jul 29, 2010 to Feb 9, 2024.

DateSiteProductClassificationFEI
Feb 9, 2024Xochimilco, MexicoVeterinaryVoluntary Action Indicated (VAI)1000183111
May 20, 2022Xochimilco, MexicoDrugsVoluntary Action Indicated (VAI)1000183111
Dec 6, 2019Xochimilco, MexicoDrugsOfficial Action Indicated (OAI)1000183111
Dec 8, 2017Xochimilco, MexicoDrugsNo Action Indicated (NAI)1000183111
Nov 20, 2015Xochimilco, MexicoDrugsNo Action Indicated (NAI)1000183111
Jun 25, 2013Xochimilco, MexicoDrugsNo Action Indicated (NAI)1000183111
Jul 29, 2010Xochimilco, MexicoVeterinaryNo Action Indicated (NAI)1000183111
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 1000183111Xochimilco, Mexico7Feb 9, 2024

BOEHRINGER INGELHEIM PROMECO S.A. De C.V. and the FDA: common questions

Has BOEHRINGER INGELHEIM PROMECO S.A. De C.V. received an FDA warning letter?

No FDA warning letter addressed to the name "BOEHRINGER INGELHEIM PROMECO S.A. De C.V." 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 BOEHRINGER INGELHEIM PROMECO S.A. De C.V. received an FDA Form 483?

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

When did the FDA last inspect BOEHRINGER INGELHEIM PROMECO S.A. De C.V.?

The most recent FDA inspection on file ended Feb 9, 2024 at Xochimilco, Mexico and was classified VAI. FDA has 7 inspections of BOEHRINGER INGELHEIM PROMECO 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.