Boehringer Ingelheim Animal Health Do Brasil Ltda — FDA Facility Profile

FEI 3002764224

Boehringer Ingelheim Animal Health Do Brasil Ltda is an FDA-registered facility (FEI 3002764224) located in CEP 13148-914, BR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 15, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
3

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jun 15, 2023Voluntary Action Indicated (VAI)No citations listed
Dec 13, 2022Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Absence of Written Procedures (21 CFR 211.100(a))
Actual vs. theoretical yields not determined (21 CFR 211.103)
Investigations of discrepancies, failures (21 CFR 211.192)
Feb 7, 2017Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Jul 2, 2013Voluntary Action Indicated (VAI)No citations listed
May 20, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Boehringer Ingelheim Animal Health Do Brasil Ltda.
Location
CEP 13148-914 (BR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL
Source
decrs

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