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Fresenius Kabi Malaysia Sbn Bhd

✅ Low Risk

FEI: 3012288831 • Petaling Jaya • MALAYSIA

FEI

FEI Number

3012288831

📍

Location

Petaling Jaya

🇲🇾

Country

MALAYSIA
🏢

Address

3-1 & 3-2 Axis Technology Centrelot 13, , Petaling Jaya, , Malaysia

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/4/2020
Latest Refusal
9/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/4/2020
81GKTSEPARATOR, AUTOMATED, BLOOD CELL
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Fresenius Kabi Malaysia Sbn Bhd's FDA import refusal history?

Fresenius Kabi Malaysia Sbn Bhd (FEI: 3012288831) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2020 to 9/4/2020.

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. Fresenius Kabi Malaysia Sbn Bhd's FEI number is 3012288831.

What types of violations has Fresenius Kabi Malaysia Sbn Bhd received?

Fresenius Kabi Malaysia Sbn Bhd 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 Fresenius Kabi Malaysia Sbn Bhd come from?

All FDA import refusal data for Fresenius Kabi Malaysia Sbn Bhd 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.