BBI Enzymes (USA) Limited
✅ Low Risk
FEI: 1000188748 • Pontypool, Gwent • UNITED KINGDOM
FEI Number
1000188748
Location
Pontypool, Gwent
Country
UNITED KINGDOMAddress
Unit 6 Gilchrist Thomas Industrial Estat, , Pontypool, Gwent, United Kingdom
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/14/2002 | 64EIY99ENZYME N.E.C. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BBI Enzymes (USA) Limited's FDA import refusal history?
BBI Enzymes (USA) Limited (FEI: 1000188748) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2002 to 2/14/2002.
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. BBI Enzymes (USA) Limited's FEI number is 1000188748.
What types of violations has BBI Enzymes (USA) Limited received?
BBI Enzymes (USA) 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 BBI Enzymes (USA) Limited come from?
All FDA import refusal data for BBI Enzymes (USA) 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.