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Aspen SA Sterile Operations (Pty) Ltd.

✅ Low Risk

FEI: 3007490529 • Port Elizabeth, Eastern Cape • SOUTH AFRICA

FEI

FEI Number

3007490529

📍

Location

Port Elizabeth, Eastern Cape

🇿🇦
🏢

Address

8b Gibaud Road, , Port Elizabeth, Eastern Cape, South Africa

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/27/2019
Latest Refusal
8/27/2019
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
8/27/2019
86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Aspen SA Sterile Operations (Pty) Ltd.'s FDA import refusal history?

Aspen SA Sterile Operations (Pty) Ltd. (FEI: 3007490529) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2019 to 8/27/2019.

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. Aspen SA Sterile Operations (Pty) Ltd.'s FEI number is 3007490529.

What types of violations has Aspen SA Sterile Operations (Pty) Ltd. received?

Aspen SA Sterile Operations (Pty) 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 Aspen SA Sterile Operations (Pty) Ltd. come from?

All FDA import refusal data for Aspen SA Sterile Operations (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.