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RPB S.A.

⚠️ Moderate Risk

FEI: 3011752516 • Gualeguaychu, Entre Rios • ARGENTINA

FEI

FEI Number

3011752516

📍

Location

Gualeguaychu, Entre Rios

🇦🇷

Country

ARGENTINA
🏢

Address

Ruta Nacional 14 Km 58, , Gualeguaychu, Entre Rios, Argentina

Moderate Risk

FDA Import Risk Assessment

44.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
3/2/2007
Latest Refusal
3/1/2007
Earliest Refusal

Score Breakdown

Violation Severity
81.3×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

624×

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).

833×

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.

481×

NEEDS ACID

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.

Refusal History

DateProductViolationsDivision
3/2/2007
21DDF99MIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
3/2/2007
21DDT99MIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
3/2/2007
21VDF02BANANA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
48NEEDS ACID
62NEEDS FCE
Florida District Office (FLA-DO)
3/1/2007
09CFT10MILK, VITAMIN D
62NEEDS FCE
83NO PROCESS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

RPB S.A. (FEI: 3011752516) has 4 FDA import refusal record(s) in our database, spanning from 3/1/2007 to 3/2/2007.

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. RPB S.A.'s FEI number is 3011752516.

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

RPB S.A. 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 RPB S.A. come from?

All FDA import refusal data for RPB 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.