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FIDSON HEALTH CARE

⚠️ High Risk

FEI: 3019670611 • Ota • NIGERIA

FEI

FEI Number

3019670611

📍

Location

Ota

🇳🇬

Country

NIGERIA
🏢

Address

Km 38 Lagos-Abeokuta Ex, , Ota, , Nigeria

High Risk

FDA Import Risk Assessment

51.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
2
Unique Violations
2/13/2024
Latest Refusal
8/18/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
46.7×20%
Frequency
30.0×10%
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

753×

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).

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).

Refusal History

DateProductViolationsDivision
2/13/2024
62GDL99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/25/2024
61PDY99ANTI-DIABETIC N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/18/2023
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FIDSON HEALTH CARE's FDA import refusal history?

FIDSON HEALTH CARE (FEI: 3019670611) has 3 FDA import refusal record(s) in our database, spanning from 8/18/2023 to 2/13/2024.

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. FIDSON HEALTH CARE's FEI number is 3019670611.

What types of violations has FIDSON HEALTH CARE received?

FIDSON HEALTH CARE 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 FIDSON HEALTH CARE come from?

All FDA import refusal data for FIDSON HEALTH CARE 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.