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Ropack, Inc. (Site A & B)

⚠️ Moderate Risk

FEI: 3002674295 • Anjou, Quebec • CANADA

FEI

FEI Number

3002674295

📍

Location

Anjou, Quebec

🇨🇦

Country

CANADA
🏢

Address

10801 Mirabeau St, , Anjou, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/11/2015
Latest Refusal
3/11/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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

DateProductViolationsDivision
3/11/2015
60IDR01POTASSIUM CITRATE (ALKALIZER)
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Ropack, Inc. (Site A & B)'s FDA import refusal history?

Ropack, Inc. (Site A & B) (FEI: 3002674295) has 1 FDA import refusal record(s) in our database, spanning from 3/11/2015 to 3/11/2015.

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. Ropack, Inc. (Site A & B)'s FEI number is 3002674295.

What types of violations has Ropack, Inc. (Site A & B) received?

Ropack, Inc. (Site A & B) 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 Ropack, Inc. (Site A & B) come from?

All FDA import refusal data for Ropack, Inc. (Site A & B) 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.