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ELITE SURGICAL SUPPLIES (PTY) LTD

⚠️ Moderate Risk

FEI: 3005325790 • Pretoria, Gauteng • SOUTH AFRICA

FEI

FEI Number

3005325790

📍

Location

Pretoria, Gauteng

🇿🇦
🏢

Address

Persequor Technopark, Persequor, 54 De Havilland Crescent, Pretoria, Gauteng, South Africa

Moderate Risk

FDA Import Risk Assessment

39.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
11/3/2005
Latest Refusal
11/3/2005
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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).

5086×

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
11/3/2005
87HXXSCREWDRIVER
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/3/2005
80KZHINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/3/2005
87MRWSYSTEM, FACET SCREW SPINAL DEVICE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/3/2005
87HWCSCREW, FIXATION, BONE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/3/2005
87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/3/2005
87LYQACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is ELITE SURGICAL SUPPLIES (PTY) LTD's FDA import refusal history?

ELITE SURGICAL SUPPLIES (PTY) LTD (FEI: 3005325790) has 6 FDA import refusal record(s) in our database, spanning from 11/3/2005 to 11/3/2005.

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. ELITE SURGICAL SUPPLIES (PTY) LTD's FEI number is 3005325790.

What types of violations has ELITE SURGICAL SUPPLIES (PTY) LTD received?

ELITE SURGICAL SUPPLIES (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 ELITE SURGICAL SUPPLIES (PTY) LTD come from?

All FDA import refusal data for ELITE SURGICAL SUPPLIES (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.