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Sea Oyster Packer

⚠️ Moderate Risk

FEI: 3011269769 • Butterworth, Pulau Pinang • MALAYSIA

FEI

FEI Number

3011269769

📍

Location

Butterworth, Pulau Pinang

🇲🇾

Country

MALAYSIA
🏢

Address

No. 8 Medan Mak Mandin, , Butterworth, Pulau Pinang, Malaysia

Moderate Risk

FDA Import Risk Assessment

49.2
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
8/31/2015
Latest Refusal
7/7/2015
Earliest Refusal

Score Breakdown

Violation Severity
84.5×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

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

32205×

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.

Refusal History

DateProductViolationsDivision
8/31/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Southwest Import District Office (SWI-DO)
8/31/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Southwest Import District Office (SWI-DO)
8/6/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
8/6/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)
8/6/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
Los Angeles District Office (LOS-DO)
7/7/2015
16XFD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sea Oyster Packer's FDA import refusal history?

Sea Oyster Packer (FEI: 3011269769) has 6 FDA import refusal record(s) in our database, spanning from 7/7/2015 to 8/31/2015.

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. Sea Oyster Packer's FEI number is 3011269769.

What types of violations has Sea Oyster Packer received?

Sea Oyster Packer 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 Sea Oyster Packer come from?

All FDA import refusal data for Sea Oyster Packer 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.