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PE Packaging, LLC dba Prime Packaging

⚠️ Moderate Risk

FEI: 3005051865 • Medley, FL • UNITED STATES

FEI

FEI Number

3005051865

📍

Location

Medley, FL

🇺🇸
🏢

Address

9165 Nw 101st St, , Medley, FL, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/14/2007
Latest Refusal
5/14/2007
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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).

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
5/14/2007
61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is PE Packaging, LLC dba Prime Packaging's FDA import refusal history?

PE Packaging, LLC dba Prime Packaging (FEI: 3005051865) has 1 FDA import refusal record(s) in our database, spanning from 5/14/2007 to 5/14/2007.

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. PE Packaging, LLC dba Prime Packaging's FEI number is 3005051865.

What types of violations has PE Packaging, LLC dba Prime Packaging received?

PE Packaging, LLC dba Prime Packaging 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 PE Packaging, LLC dba Prime Packaging come from?

All FDA import refusal data for PE Packaging, LLC dba Prime Packaging 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.