Bomac Laboratories Limited
⚠️ Moderate Risk
FEI: 3004684575 • Auckland, NZ-AUK • NEW ZEALAND
FEI Number
3004684575
Location
Auckland, NZ-AUK
Country
NEW ZEALANDAddress
CNR Wiri Station Road and Hobill Ave., , Auckland, NZ-AUK, New Zealand
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
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
Frequently Asked Questions
What is Bomac Laboratories Limited's FDA import refusal history?
Bomac Laboratories Limited (FEI: 3004684575) has 2 FDA import refusal record(s) in our database, spanning from 11/29/2007 to 12/28/2011.
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. Bomac Laboratories Limited's FEI number is 3004684575.
What types of violations has Bomac Laboratories Limited received?
Bomac Laboratories Limited has been cited for 1 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 Bomac Laboratories Limited come from?
All FDA import refusal data for Bomac Laboratories Limited 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.