ImportRefusal LogoImportRefusal

Nic Corporation Sdn Bhd

⚠️ Moderate Risk

FEI: 3007139429 • Geopark • MALAYSIA

FEI

FEI Number

3007139429

📍

Location

Geopark

🇲🇾

Country

MALAYSIA
🏢

Address

1 Ocean Front Estate, , Geopark, , Malaysia

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
6/6/2012
Latest Refusal
5/1/2012
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

167×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1181×

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).

Refusal History

DateProductViolationsDivision
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
6/6/2012
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
San Francisco District Office (SAN-DO)
5/1/2012
65LBL11TITANIUM DIOXIDE (PROTECTANT)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Nic Corporation Sdn Bhd's FDA import refusal history?

Nic Corporation Sdn Bhd (FEI: 3007139429) has 8 FDA import refusal record(s) in our database, spanning from 5/1/2012 to 6/6/2012.

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. Nic Corporation Sdn Bhd's FEI number is 3007139429.

What types of violations has Nic Corporation Sdn Bhd received?

Nic Corporation 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 Nic Corporation Sdn Bhd come from?

All FDA import refusal data for Nic Corporation 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.