Redepa S.A.
⚠️ Moderate Risk
FEI: 3004115813 • Pcia.De Buenos Aires • ARGENTINA
FEI Number
3004115813
Location
Pcia.De Buenos Aires
Country
ARGENTINAAddress
Santa Catalina 184, , Pcia.De Buenos Aires, , Argentina
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2006 | 20QET04QUINCE, DRIED OR PASTE | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 25LCT12SWEET POTATO, DRIED OR PASTE | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 25JYT12SWEET POTATO (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Redepa S.A.'s FDA import refusal history?
Redepa S.A. (FEI: 3004115813) has 3 FDA import refusal record(s) in our database, spanning from 6/17/2004 to 9/8/2006.
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. Redepa S.A.'s FEI number is 3004115813.
What types of violations has Redepa S.A. received?
Redepa S.A. 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 Redepa S.A. come from?
All FDA import refusal data for Redepa 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.