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Noven Pharmaceuticals Inc

⚠️ Moderate Risk

FEI: 1000222037 • Miami, FL • UNITED STATES

FEI

FEI Number

1000222037

📍

Location

Miami, FL

🇺🇸
🏢

Address

11960 Sw 144th St, , Miami, FL, United States

Moderate Risk

FDA Import Risk Assessment

35.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/12/2016
Latest Refusal
12/20/2006
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.2×10%
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

33401×

DE/RX KIT

The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

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
2/12/2016
64GCD99ESTROGEN N.E.C.
3340DE/RX KIT
Florida District Office (FLA-DO)
12/20/2006
64GCY07ESTRADIOL (ESTROGEN)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Noven Pharmaceuticals Inc's FDA import refusal history?

Noven Pharmaceuticals Inc (FEI: 1000222037) has 2 FDA import refusal record(s) in our database, spanning from 12/20/2006 to 2/12/2016.

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. Noven Pharmaceuticals Inc's FEI number is 1000222037.

What types of violations has Noven Pharmaceuticals Inc received?

Noven Pharmaceuticals Inc 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 Noven Pharmaceuticals Inc come from?

All FDA import refusal data for Noven Pharmaceuticals 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.