Intergen Biomanufacturing Corp.
⚠️ Moderate Risk
FEI: 3004707981 • Toronto, Ontario • CANADA
FEI Number
3004707981
Location
Toronto, Ontario
Country
CANADAAddress
55 Glen Scarlett Rd, , Toronto, Ontario, 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.
Refusal History
Frequently Asked Questions
What is Intergen Biomanufacturing Corp.'s FDA import refusal history?
Intergen Biomanufacturing Corp. (FEI: 3004707981) has 2 FDA import refusal record(s) in our database, spanning from 12/20/2001 to 8/20/2003.
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. Intergen Biomanufacturing Corp.'s FEI number is 3004707981.
What types of violations has Intergen Biomanufacturing Corp. received?
Intergen Biomanufacturing Corp. 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 Intergen Biomanufacturing Corp. come from?
All FDA import refusal data for Intergen Biomanufacturing Corp. 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.