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Commonwealth Wholesale Corp

⚠️ Moderate Risk

FEI: 3002701389 • Hallandale Beach, FL • UNITED STATES

FEI

FEI Number

3002701389

📍

Location

Hallandale Beach, FL

🇺🇸
🏢

Address

1250 E Hallandale Beach Blvd Ph 3, , Hallandale Beach, FL, United States

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
12/10/2008
Latest Refusal
12/11/2001
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.9×10%
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

1181×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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
12/10/2008
61HBL99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
12/11/2001
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
New England District Office (NWE-DO)

Frequently Asked Questions

What is Commonwealth Wholesale Corp's FDA import refusal history?

Commonwealth Wholesale Corp (FEI: 3002701389) has 2 FDA import refusal record(s) in our database, spanning from 12/11/2001 to 12/10/2008.

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. Commonwealth Wholesale Corp's FEI number is 3002701389.

What types of violations has Commonwealth Wholesale Corp received?

Commonwealth Wholesale Corp 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 Commonwealth Wholesale Corp come from?

All FDA import refusal data for Commonwealth Wholesale Corp 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.