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PRODUCTOS NOSTALGICOS, S.A. de C.V.

⚠️ Moderate Risk

FEI: 2000040135 • San Salvador, SV-SS • EL SALVADOR

FEI

FEI Number

2000040135

📍

Location

San Salvador, SV-SS

🇸🇻
🏢

Address

Final 31 Calle Poniente No. 1217, Colonia Layco, San Salvador, SV-SS, El Salvador

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/23/2008
Latest Refusal
1/23/2008
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

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
1/23/2008
25ECI99MIXED VEGETABLES, N.E.C.
62NEEDS FCE
83NO PROCESS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is PRODUCTOS NOSTALGICOS, S.A. de C.V.'s FDA import refusal history?

PRODUCTOS NOSTALGICOS, S.A. de C.V. (FEI: 2000040135) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2008 to 1/23/2008.

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. PRODUCTOS NOSTALGICOS, S.A. de C.V.'s FEI number is 2000040135.

What types of violations has PRODUCTOS NOSTALGICOS, S.A. de C.V. received?

PRODUCTOS NOSTALGICOS, 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 PRODUCTOS NOSTALGICOS, S.A. de C.V. come from?

All FDA import refusal data for PRODUCTOS NOSTALGICOS, 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.