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Criticare Systems (Malaysia) Sdn. Bhd.

✅ Low Risk

FEI: 3008727514 • Nusajaya, Johor • MALAYSIA

FEI

FEI Number

3008727514

📍

Location

Nusajaya, Johor

🇲🇾

Country

MALAYSIA
🏢

Address

No. 19 Jalan Mega 1/8, Taman Perindustrian Nusa Cemerlang, Nusajaya, Johor, 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
2
Unique Violations
3/16/2015
Latest Refusal
3/16/2015
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

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
3/16/2015
74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
2780DEVICEGMPS
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Criticare Systems (Malaysia) Sdn. Bhd.'s FDA import refusal history?

Criticare Systems (Malaysia) Sdn. Bhd. (FEI: 3008727514) has 1 FDA import refusal record(s) in our database, spanning from 3/16/2015 to 3/16/2015.

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. Criticare Systems (Malaysia) Sdn. Bhd.'s FEI number is 3008727514.

What types of violations has Criticare Systems (Malaysia) Sdn. Bhd. received?

Criticare Systems (Malaysia) Sdn. Bhd. 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 Criticare Systems (Malaysia) Sdn. Bhd. come from?

All FDA import refusal data for Criticare Systems (Malaysia) Sdn. 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.