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Stemcell Technologies

⚠️ High Risk

FEI: 1000215504 • Vancouver, BC • CANADA

FEI

FEI Number

1000215504

📍

Location

Vancouver, BC

🇨🇦

Country

CANADA
🏢

Address

808 777 West Broadway, , Vancouver, BC, Canada

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
10/3/2002
Latest Refusal
10/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

787×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/3/2002
88LDTREAGENT, GENERAL PURPOSE
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
77KBRNEEDLE, TONSIL SUTURING
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
88LDTREAGENT, GENERAL PURPOSE
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
88LDTREAGENT, GENERAL PURPOSE
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
57FY09ANTI-HUMAN SERUM (IN-VITRO DIAGNOSTIC PRODUCTS)
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
88LDTREAGENT, GENERAL PURPOSE
78STERILITY
New Orleans District Office (NOL-DO)
10/3/2002
88IEXGELATIN
78STERILITY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Stemcell Technologies's FDA import refusal history?

Stemcell Technologies (FEI: 1000215504) has 7 FDA import refusal record(s) in our database, spanning from 10/3/2002 to 10/3/2002.

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. Stemcell Technologies's FEI number is 1000215504.

What types of violations has Stemcell Technologies received?

Stemcell Technologies has been cited for 1 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 Stemcell Technologies come from?

All FDA import refusal data for Stemcell Technologies 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.