Enzymatica AB
⚠️ Moderate Risk
FEI: 3011775405 • Lund, Skane Lan • SWEDEN
FEI Number
3011775405
Location
Lund, Skane Lan
Country
SWEDENAddress
Forskningsbyn Ideon, Ideon Science Park, Lund, Skane Lan, Sweden
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/20/2015 | 68KDL10SMALL ANIMAL WOUND DRESSING | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 2/20/2015 | 68KDL10SMALL ANIMAL WOUND DRESSING | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 2/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 2/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 2/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Enzymatica AB's FDA import refusal history?
Enzymatica AB (FEI: 3011775405) has 5 FDA import refusal record(s) in our database, spanning from 2/20/2015 to 2/20/2015.
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. Enzymatica AB's FEI number is 3011775405.
What types of violations has Enzymatica AB received?
Enzymatica AB 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 Enzymatica AB come from?
All FDA import refusal data for Enzymatica AB 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.