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Pasteles De El Salvador, S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3004357480 • San Salvador • EL SALVADOR

FEI

FEI Number

3004357480

📍

Location

San Salvador

🇸🇻
🏢

Address

Frente A Terminal De Occidente, Calle Antigua Ferrocarril # 10, San Salvador, , El Salvador

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
8/22/2014
Latest Refusal
11/20/2003
Earliest Refusal

Score Breakdown

Violation Severity
81.4×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
6.5×10%
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

116×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

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
8/22/2014
03JGT06FRUIT FILLED FILLED/ICED COOKIES,BISCUITS AND WAFERS
11UNSAFE COL
Division of Southeast Imports (DSEI)
8/22/2014
03HGT01VANILLA PLAIN COOKIE,BISCUIT AND WAFER
11UNSAFE COL
Division of Southeast Imports (DSEI)
8/22/2014
03HGT01VANILLA PLAIN COOKIE,BISCUIT AND WAFER
11UNSAFE COL
Division of Southeast Imports (DSEI)
8/22/2014
03HGT09FRUIT/FRUIT FLAVORED PLAIN COOKIES, BISCUITS AND WAFERS
11UNSAFE COL
Division of Southeast Imports (DSEI)
4/9/2008
03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
Florida District Office (FLA-DO)
1/7/2008
03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
Florida District Office (FLA-DO)
11/20/2003
03AFB03BISCUITS
324NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pasteles De El Salvador, S.A. DE C.V.'s FDA import refusal history?

Pasteles De El Salvador, S.A. DE C.V. (FEI: 3004357480) has 7 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 8/22/2014.

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. Pasteles De El Salvador, S.A. DE C.V.'s FEI number is 3004357480.

What types of violations has Pasteles De El Salvador, S.A. DE C.V. received?

Pasteles De El Salvador, S.A. DE C.V. 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 Pasteles De El Salvador, S.A. DE C.V. come from?

All FDA import refusal data for Pasteles De El Salvador, S.A. DE C.V. 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.