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Okeanos Co., Ltd.

⚠️ Moderate Risk

FEI: 13256 • Muang Samut Sakhon, Samut Sakhon • THAILAND

FEI

FEI Number

13256

📍

Location

Muang Samut Sakhon, Samut Sakhon

🇹🇭

Country

THAILAND
🏢

Address

Muang District, 30 Ekachai Road, Tambon Nadee, Muang Samut Sakhon, Samut Sakhon, Thailand

Moderate Risk

FDA Import Risk Assessment

43.7
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
12/3/2003
Latest Refusal
10/25/2001
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
19.0×10%
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

28603×

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

91×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

Refusal History

DateProductViolationsDivision
12/3/2003
16JGT05SHRIMP & PRAWNS
2860VETDRUGRES
Division of Southeast Imports (DSEI)
11/4/2003
16JGD05SHRIMP & PRAWNS
2860VETDRUGRES
Florida District Office (FLA-DO)
3/7/2003
16JGT05SHRIMP & PRAWNS
2860VETDRUGRES
Philadelphia District Office (PHI-DO)
10/25/2001
16JFD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)

Frequently Asked Questions

What is Okeanos Co., Ltd.'s FDA import refusal history?

Okeanos Co., Ltd. (FEI: 13256) has 4 FDA import refusal record(s) in our database, spanning from 10/25/2001 to 12/3/2003.

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. Okeanos Co., Ltd.'s FEI number is 13256.

What types of violations has Okeanos Co., Ltd. received?

Okeanos Co., Ltd. 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 Okeanos Co., Ltd. come from?

All FDA import refusal data for Okeanos Co., Ltd. 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.