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United Pharma Mfg

⚠️ Moderate Risk

FEI: 3012239613 • Amman • JORDAN

FEI

FEI Number

3012239613

📍

Location

Amman

🇯🇴

Country

JORDAN
🏢

Address

Ubay Bin Muath St 57, , Amman, , Jordan

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/27/2022
Latest Refusal
1/20/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
10.5×20%
Frequency
3.8×10%
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

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).

Refusal History

DateProductViolationsDivision
4/27/2022
65CCA99NUTRIENT/TONIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/20/2017
56JCO20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is United Pharma Mfg's FDA import refusal history?

United Pharma Mfg (FEI: 3012239613) has 2 FDA import refusal record(s) in our database, spanning from 1/20/2017 to 4/27/2022.

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. United Pharma Mfg's FEI number is 3012239613.

What types of violations has United Pharma Mfg received?

United Pharma Mfg has been cited for 1 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 United Pharma Mfg come from?

All FDA import refusal data for United Pharma Mfg 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.