ImportRefusal LogoImportRefusal

SmartPEP (Canada) Biological Technology Research Ltd.

Low Risk

FEI: 3023573794 • Richmond, British Columbia • CANADA

FEI

FEI Number

3023573794

📍

Location

Richmond, British Columbia

🇨🇦

Country

CANADA
🏢

Address

110-11611 No. 5 Rd, , Richmond, British Columbia, Canada

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
8/28/2018
Latest Refusal
8/28/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
8/28/2018
54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
3864NCONTACT
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SmartPEP (Canada) Biological Technology Research Ltd.'s FDA import refusal history?

SmartPEP (Canada) Biological Technology Research Ltd. (FEI: 3023573794) has 1 FDA import refusal record(s) in our database, spanning from 8/28/2018 to 8/28/2018.

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. SmartPEP (Canada) Biological Technology Research Ltd.'s FEI number is 3023573794.

What types of violations has SmartPEP (Canada) Biological Technology Research Ltd. received?

SmartPEP (Canada) Biological Technology Research Ltd. 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 SmartPEP (Canada) Biological Technology Research Ltd. come from?

All FDA import refusal data for SmartPEP (Canada) Biological Technology Research Ltd. 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.