BioEnvelop Inc
⚠️ Moderate Risk
FEI: 3004508786 • Saint-hyacinthe, Quebec • CANADA
FEI Number
3004508786
Location
Saint-hyacinthe, Quebec
Country
CANADAAddress
3275 Boul Choquette, Unit #3, Saint-hyacinthe, Quebec, 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
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is BioEnvelop Inc's FDA import refusal history?
BioEnvelop Inc (FEI: 3004508786) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2008 to 9/22/2008.
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. BioEnvelop Inc's FEI number is 3004508786.
What types of violations has BioEnvelop Inc received?
BioEnvelop Inc 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 BioEnvelop Inc come from?
All FDA import refusal data for BioEnvelop Inc 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.