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Nicalapia S.A.

⚠️ High Risk

FEI: 3003119233 • Leon, Nagarote • NICARAGUA

FEI

FEI Number

3003119233

📍

Location

Leon, Nagarote

🇳🇮

Country

NICARAGUA
🏢

Address

Km 34 1/2 Carretera Nueva A Leon, Frente a cementeria Hocim, Leon, Nagarote, Nicaragua

High Risk

FDA Import Risk Assessment

60.9
LowModerateHighCritical

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

Statistics

16
Total Refusals
6
Unique Violations
11/1/2024
Latest Refusal
9/14/2010
Earliest Refusal

Score Breakdown

Violation Severity
77.1×40%
Refusal Volume
45.6×30%
Recency
76.1×20%
Frequency
11.3×10%
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

24915×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

3243×

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)).

4823×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

25801×

MFRHACCP

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).

3201×

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.

3211×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
11/1/2024
16JGD06SPINY LOBSTER, ROCK LOBSTER
249FILTHY
324NO ENGLISH
482NUTRIT LBL
Division of Southeast Imports (DSEI)
11/1/2024
16JGD06SPINY LOBSTER, ROCK LOBSTER
249FILTHY
324NO ENGLISH
482NUTRIT LBL
Division of Southeast Imports (DSEI)
11/1/2024
16JGD06SPINY LOBSTER, ROCK LOBSTER
249FILTHY
324NO ENGLISH
482NUTRIT LBL
Division of Southeast Imports (DSEI)
10/18/2024
16JGD06SPINY LOBSTER, ROCK LOBSTER
249FILTHY
Division of Southeast Imports (DSEI)
10/18/2024
16JGD06SPINY LOBSTER, ROCK LOBSTER
249FILTHY
Division of Southeast Imports (DSEI)
2/28/2023
16AVT17GROUPERS
249FILTHY
Division of Southeast Imports (DSEI)
12/15/2022
16AVT17GROUPERS
249FILTHY
Division of Southeast Imports (DSEI)
6/8/2022
16AVT51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
2/8/2019
16AGD51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
6/15/2018
16AGC51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
6/15/2018
16AGC51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
6/15/2018
16AGD51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
5/21/2018
16AVT51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
1/8/2018
16AVT51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
10/16/2012
16AGC51MAHI MAHI
2580MFRHACCP
Florida District Office (FLA-DO)
9/14/2010
16JGD01CRAB
249FILTHY
320LACKS FIRM
321LACKS N/C
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Nicalapia S.A.'s FDA import refusal history?

Nicalapia S.A. (FEI: 3003119233) has 16 FDA import refusal record(s) in our database, spanning from 9/14/2010 to 11/1/2024.

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. Nicalapia S.A.'s FEI number is 3003119233.

What types of violations has Nicalapia S.A. received?

Nicalapia S.A. has been cited for 6 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 Nicalapia S.A. come from?

All FDA import refusal data for Nicalapia S.A. 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.