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Frank Pellegrino

⚠️ Moderate Risk

FEI: 3004058828 • Toronto, ON • CANADA

FEI

FEI Number

3004058828

📍

Location

Toronto, ON

🇨🇦

Country

CANADA
🏢

Address

56 Bellefair Ave, , Toronto, ON, Canada

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/18/2003
Latest Refusal
8/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
8/18/2003
31KMT99TEA, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/18/2003
55QY30WHITE OINTMENT (PHARMACEUTIC NECESSITY - OLEAGINOUS)
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Frank Pellegrino's FDA import refusal history?

Frank Pellegrino (FEI: 3004058828) has 2 FDA import refusal record(s) in our database, spanning from 8/18/2003 to 8/18/2003.

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. Frank Pellegrino's FEI number is 3004058828.

What types of violations has Frank Pellegrino received?

Frank Pellegrino 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 Frank Pellegrino come from?

All FDA import refusal data for Frank Pellegrino 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.