KAREN MARINE PHYTOPLANKTON
⚠️ Moderate Risk
FEI: 3012577251 • Sackville, NB • CANADA
FEI Number
3012577251
Location
Sackville, NB
Country
CANADAAddress
23C York Street, , Sackville, NB, 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).
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
Frequently Asked Questions
What is KAREN MARINE PHYTOPLANKTON's FDA import refusal history?
KAREN MARINE PHYTOPLANKTON (FEI: 3012577251) has 1 FDA import refusal record(s) in our database, spanning from 8/10/2016 to 8/10/2016.
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. KAREN MARINE PHYTOPLANKTON's FEI number is 3012577251.
What types of violations has KAREN MARINE PHYTOPLANKTON received?
KAREN MARINE PHYTOPLANKTON has been cited for 2 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 KAREN MARINE PHYTOPLANKTON come from?
All FDA import refusal data for KAREN MARINE PHYTOPLANKTON 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.