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OCEAN FAMOUS SDN BHD

⚠️ Moderate Risk

FEI: 3007935491 • Minyak14100 Spt, Pulau Pinang • MALAYSIA

FEI

FEI Number

3007935491

📍

Location

Minyak14100 Spt, Pulau Pinang

🇲🇾

Country

MALAYSIA
🏢

Address

2nd Floor, Plot 99b, Jln Perindustrian, Bkt Minyak 5,Kws Perindustrian Bkt, Minyak14100 Spt, Pulau Pinang, Malaysia

Moderate Risk

FDA Import Risk Assessment

48.4
LowModerateHighCritical

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

Statistics

8
Total Refusals
4
Unique Violations
11/12/2014
Latest Refusal
7/30/2014
Earliest Refusal

Score Breakdown

Violation Severity
74.6×40%
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

32208×

NITROFURAN

The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely nitrofurans, that is unsafe.

28607×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

3205×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

2384×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

DateProductViolationsDivision
11/12/2014
16XGD99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C.,
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
11/4/2014
16XGD99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C.,
2860VETDRUGRES
3220NITROFURAN
Southwest Import District Office (SWI-DO)
8/8/2014
16XGD99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C.,
2860VETDRUGRES
3220NITROFURAN
Southwest Import District Office (SWI-DO)
7/30/2014
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
320LACKS FIRM
3220NITROFURAN
Division of Northeast Imports (DNEI)
7/30/2014
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
238UNSAFE ADD
2860VETDRUGRES
320LACKS FIRM
3220NITROFURAN
Division of Northeast Imports (DNEI)
7/30/2014
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
238UNSAFE ADD
2860VETDRUGRES
320LACKS FIRM
3220NITROFURAN
Division of Northeast Imports (DNEI)
7/30/2014
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
238UNSAFE ADD
2860VETDRUGRES
320LACKS FIRM
3220NITROFURAN
Division of Northeast Imports (DNEI)
7/30/2014
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
238UNSAFE ADD
320LACKS FIRM
3220NITROFURAN
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is OCEAN FAMOUS SDN BHD's FDA import refusal history?

OCEAN FAMOUS SDN BHD (FEI: 3007935491) has 8 FDA import refusal record(s) in our database, spanning from 7/30/2014 to 11/12/2014.

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. OCEAN FAMOUS SDN BHD's FEI number is 3007935491.

What types of violations has OCEAN FAMOUS SDN BHD received?

OCEAN FAMOUS SDN BHD has been cited for 4 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 OCEAN FAMOUS SDN BHD come from?

All FDA import refusal data for OCEAN FAMOUS 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.