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Pharmascience Inc.

⚠️ Moderate Risk

FEI: 3002806578 • La Prairie, Quebec • CANADA

FEI

FEI Number

3002806578

📍

Location

La Prairie, Quebec

🇨🇦

Country

CANADA
🏢

Address

100 De L'Industrie Blvd, , La Prairie, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
11/24/2023
Latest Refusal
8/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
64.0×40%
Refusal Volume
22.3×30%
Recency
57.4×20%
Frequency
2.5×10%
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

1182×

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).

752×

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).

38721×

708LISTING

It has been determined the drug is not included in a list required by Section 510(j).

Refusal History

DateProductViolationsDivision
11/24/2023
61PDB55METFORMIN HCL (ANTI-DIABETIC)
3872708LISTING
Division of Southeast Imports (DSEI)
3/9/2023
62IDA31METHOTREXATE (ANTI-NEOPLASTIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/24/2011
56YIN99ANTIBIOTIC N.E.C.
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pharmascience Inc.'s FDA import refusal history?

Pharmascience Inc. (FEI: 3002806578) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 11/24/2023.

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. Pharmascience Inc.'s FEI number is 3002806578.

What types of violations has Pharmascience Inc. received?

Pharmascience Inc. has been cited for 3 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 Pharmascience Inc. come from?

All FDA import refusal data for Pharmascience Inc. 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.