Sera Aquaristik Canada Limited
⚠️ Moderate Risk
FEI: 3003688151 • Scarborough, ON • CANADA
FEI Number
3003688151
Location
Scarborough, ON
Country
CANADAAddress
1160 Tapscott Road #15, , Scarborough, ON, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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 |
|---|---|---|---|
| 6/12/2002 | 72DMB99PET FISH FOOD N.E.C. | 308MFR INSAN | Chicago District Office (CHI-DO) |
| 6/12/2002 | 75CHCTITRIMETRIC PERMANGANATE AND BROMOPHENOL BLUE, CALCIUM | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 6/12/2002 | 68CYY99OTHER ANIMAL, N.E.C. ANTISEPTIC | 72NEW VET DR | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Sera Aquaristik Canada Limited's FDA import refusal history?
Sera Aquaristik Canada Limited (FEI: 3003688151) has 3 FDA import refusal record(s) in our database, spanning from 6/12/2002 to 6/12/2002.
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. Sera Aquaristik Canada Limited's FEI number is 3003688151.
What types of violations has Sera Aquaristik Canada Limited received?
Sera Aquaristik Canada Limited 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 Sera Aquaristik Canada Limited come from?
All FDA import refusal data for Sera Aquaristik Canada 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.