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Ocean Vision SDN. BHD.

⚠️ High Risk

FEI: 3010961279 • Bukit Mertajam, Pulau Pinang • MALAYSIA

FEI

FEI Number

3010961279

📍

Location

Bukit Mertajam, Pulau Pinang

🇲🇾

Country

MALAYSIA
🏢

Address

Jalan Persekutuan Bukit Minyak 1098, , Bukit Mertajam, Pulau Pinang, Malaysia

High Risk

FDA Import Risk Assessment

50.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

13
Total Refusals
3
Unique Violations
10/2/2015
Latest Refusal
6/1/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

322011×

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.

3207×

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.

28606×

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

Refusal History

DateProductViolationsDivision
10/2/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
10/1/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
10/1/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Division of West Coast Imports (DWCI)
10/1/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Division of West Coast Imports (DWCI)
10/1/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Division of West Coast Imports (DWCI)
9/30/2015
16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
3220NITROFURAN
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
Los Angeles District Office (LOS-DO)
6/1/2015
16XGT21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ocean Vision SDN. BHD.'s FDA import refusal history?

Ocean Vision SDN. BHD. (FEI: 3010961279) has 13 FDA import refusal record(s) in our database, spanning from 6/1/2015 to 10/2/2015.

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. Ocean Vision SDN. BHD.'s FEI number is 3010961279.

What types of violations has Ocean Vision SDN. BHD. received?

Ocean Vision SDN. BHD. has been cited for 3 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 Vision SDN. BHD. come from?

All FDA import refusal data for Ocean Vision 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.