Biopak

⚠️ Moderate Risk

FEI: 3004151192 • Edmonton, AB • CANADA

FEI

FEI Number

3004151192

📍

Location

Edmonton, AB

🇨🇦

Country

CANADA

🏢

Address

7824 51 Avenue, , Edmonton, AB, Canada

Moderate Risk

FDA Import Risk Assessment

49.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/6/2006

Latest Refusal

6/6/2006

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11810×

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).

7510×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)
6/6/2006	66VAE99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Biopak's FDA import refusal history?

Biopak (FEI: 3004151192) has 10 FDA import refusal record(s) in our database, spanning from 6/6/2006 to 6/6/2006.

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. Biopak's FEI number is 3004151192.

What types of violations has Biopak received?

Biopak 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 Biopak come from?

All FDA import refusal data for Biopak 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.