Glanbia
⚠️ Moderate Risk
FEI: 3004366991 • Monroe, WI • UNITED STATES
FEI Number
3004366991
Location
Monroe, WI
Country
UNITED STATESAddress
523 6th St, , Monroe, WI, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2006 | 71CYB02DRIED WHEY | 72NEW VET DR | New England District Office (NWE-DO) |
| 3/21/2005 | 54CBR05L-CYSTEINE (PROTEIN) | 260FALSE | New England District Office (NWE-DO) |
| 3/21/2005 | 54CBR05L-CYSTEINE (PROTEIN) | 260FALSE | New England District Office (NWE-DO) |
| 3/7/2005 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Glanbia's FDA import refusal history?
Glanbia (FEI: 3004366991) has 4 FDA import refusal record(s) in our database, spanning from 3/7/2005 to 6/29/2006.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Glanbia's FEI number is 3004366991.
What types of violations has Glanbia received?
Glanbia has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Glanbia come from?
All FDA import refusal data for Glanbia is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.