Warex Bv
⚠️ Moderate Risk
FEI: 1000470568 • 'S-Gravendeel, Zuid-Holland • NETHERLANDS
FEI Number
1000470568
Location
'S-Gravendeel, Zuid-Holland
Country
NETHERLANDSAddress
Langestraat 5-9, , 'S-Gravendeel, Zuid-Holland, Netherlands
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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2008 | 33LGT08LICORICE CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 12/14/2006 | 16YCE99FISHERY PRODUCTS, N.E.C. | Chicago District Office (CHI-DO) | |
| 11/15/2005 | 16YCE99FISHERY PRODUCTS, N.E.C. | Chicago District Office (CHI-DO) | |
| 11/21/2001 | 16XCY31MUSSELS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Warex Bv's FDA import refusal history?
Warex Bv (FEI: 1000470568) has 4 FDA import refusal record(s) in our database, spanning from 11/21/2001 to 8/22/2008.
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. Warex Bv's FEI number is 1000470568.
What types of violations has Warex Bv received?
Warex Bv has been cited for 3 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 Warex Bv come from?
All FDA import refusal data for Warex Bv 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.