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SOUTHERN MEDICAL (PTY) LTD

⚠️ Moderate Risk

FEI: 3003898943 • Irene, Gauteng • SOUTH AFRICA

FEI

FEI Number

3003898943

📍

Location

Irene, Gauteng

🇿🇦
🏢

Address

55 Regency, Route 21 Corporate Park, Irene, Pretoria, , Irene, Gauteng, South Africa

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/3/2018
Latest Refusal
1/24/2006
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.4×10%
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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/3/2018
54AYL03VITAMIN B2 (RIBOFLAVIN)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
8/11/2016
54ABL03VITAMIN B2 (RIBOFLAVIN)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
1/24/2006
87MOOORTHOPEDIC IMPLANT MATERIAL
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SOUTHERN MEDICAL (PTY) LTD's FDA import refusal history?

SOUTHERN MEDICAL (PTY) LTD (FEI: 3003898943) has 3 FDA import refusal record(s) in our database, spanning from 1/24/2006 to 10/3/2018.

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. SOUTHERN MEDICAL (PTY) LTD's FEI number is 3003898943.

What types of violations has SOUTHERN MEDICAL (PTY) LTD received?

SOUTHERN MEDICAL (PTY) LTD 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 SOUTHERN MEDICAL (PTY) LTD come from?

All FDA import refusal data for SOUTHERN MEDICAL (PTY) 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.