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KUNIMED PHARMACHEM LTD

⚠️ Moderate Risk

FEI: 3015548032 • Lagos, Cross River State • NIGERIA

FEI

FEI Number

3015548032

📍

Location

Lagos, Cross River State

🇳🇬

Country

NIGERIA
🏢

Address

18/20 Morturie Ave Vall, , Lagos, Cross River State, Nigeria

Moderate Risk

FDA Import Risk Assessment

47.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/14/2022
Latest Refusal
10/28/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
21.5×20%
Frequency
19.1×10%
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
11/14/2022
54AGA13VITAMIN C (ASCORBIC ACID)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/28/2021
54ADY13VITAMIN C (ASCORBIC ACID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KUNIMED PHARMACHEM LTD's FDA import refusal history?

KUNIMED PHARMACHEM LTD (FEI: 3015548032) has 2 FDA import refusal record(s) in our database, spanning from 10/28/2021 to 11/14/2022.

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. KUNIMED PHARMACHEM LTD's FEI number is 3015548032.

What types of violations has KUNIMED PHARMACHEM LTD received?

KUNIMED PHARMACHEM LTD 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 KUNIMED PHARMACHEM LTD come from?

All FDA import refusal data for KUNIMED PHARMACHEM LTD 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.