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Pesquera del Mar Antartico SA

⚠️ Moderate Risk

FEI: 3008088718 • Puerto Montt, Llanquihue • CHILE

FEI

FEI Number

3008088718

📍

Location

Puerto Montt, Llanquihue

🇨🇱

Country

CHILE
🏢

Address

Parque Industrial, Bima 338, Puerto Montt, Llanquihue, Chile

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/4/2013
Latest Refusal
9/9/2013
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3241×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
11/4/2013
16SGD32SALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.), COLD SMOKED, FISH
2860VETDRUGRES
Florida District Office (FLA-DO)
9/9/2013
16XVD03SALMON, ALL, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
324NO ENGLISH
Florida District Office (FLA-DO)
9/9/2013
16XVD03SALMON, ALL, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pesquera del Mar Antartico SA's FDA import refusal history?

Pesquera del Mar Antartico SA (FEI: 3008088718) has 3 FDA import refusal record(s) in our database, spanning from 9/9/2013 to 11/4/2013.

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. Pesquera del Mar Antartico SA's FEI number is 3008088718.

What types of violations has Pesquera del Mar Antartico SA received?

Pesquera del Mar Antartico SA 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 Pesquera del Mar Antartico SA come from?

All FDA import refusal data for Pesquera del Mar Antartico SA 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.