Calkins & Burke Ltd.
⚠️ Moderate Risk
FEI: 3000099043 • Vancouver, British Columbia • CANADA
FEI Number
3000099043
Location
Vancouver, British Columbia
Country
CANADAAddress
800-1500 Georgia St W, , Vancouver, British Columbia, Canada
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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LISTERIA
The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2003 | 16AGD32SALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.) | 249FILTHY | Seattle District Office (SEA-DO) |
| 8/26/2003 | 16AET32SALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.) | 62NEEDS FCE | New Orleans District Office (NOL-DO) |
| 1/9/2003 | 16JGC01CRAB | 295LISTERIA | Seattle District Office (SEA-DO) |
| 9/6/2002 | 16WYY12TUNA FISH SANDWICHES, MIXED FISHERY/SEAFOOD PRODUCTS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Calkins & Burke Ltd.'s FDA import refusal history?
Calkins & Burke Ltd. (FEI: 3000099043) has 4 FDA import refusal record(s) in our database, spanning from 9/6/2002 to 12/30/2003.
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. Calkins & Burke Ltd.'s FEI number is 3000099043.
What types of violations has Calkins & Burke Ltd. received?
Calkins & Burke Ltd. has been cited for 4 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 Calkins & Burke Ltd. come from?
All FDA import refusal data for Calkins & Burke Ltd. 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.