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Industrias Sisa S.A.C.

⚠️ Moderate Risk

FEI: 2000039522 • Lima, Lima • PERU

FEI

FEI Number

2000039522

📍

Location

Lima, Lima

🇵🇪

Country

PERU
🏢

Address

Calle Alejandro Deustua Mza. O Lote. 15, Jr Niquel 270, Urb Industrial Infantas, Los Olivos, Lima, Lima, Peru

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
3/19/2015
Latest Refusal
3/2/2015
Earliest Refusal

Score Breakdown

Violation Severity
44.0×40%
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

3242×

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)).

4822×

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.

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/19/2015
03JFT99FILLED/ICED COOKIES,BISCUITS AND WAFERS, N.E.C.
324NO ENGLISH
482NUTRIT LBL
Division of Northeast Imports (DNEI)
3/19/2015
03JFT99FILLED/ICED COOKIES,BISCUITS AND WAFERS, N.E.C.
324NO ENGLISH
482NUTRIT LBL
Division of Northeast Imports (DNEI)
3/2/2015
21LET09OLIVES, TOPPING OR SYRUP, TOPPING OR SYRUP
83NO PROCESS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Industrias Sisa S.A.C.'s FDA import refusal history?

Industrias Sisa S.A.C. (FEI: 2000039522) has 3 FDA import refusal record(s) in our database, spanning from 3/2/2015 to 3/19/2015.

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. Industrias Sisa S.A.C.'s FEI number is 2000039522.

What types of violations has Industrias Sisa S.A.C. received?

Industrias Sisa S.A.C. 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 Industrias Sisa S.A.C. come from?

All FDA import refusal data for Industrias Sisa S.A.C. 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.