C.I. Dona Paula S.A.
⚠️ Moderate Risk
FEI: 3004296257 • Itagui, Antioquia • COLOMBIA
FEI Number
3004296257
Location
Itagui, Antioquia
Country
COLOMBIAAddress
Calle 81 # 52d-107, , Itagui, Antioquia, Colombia
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.
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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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 |
|---|---|---|---|
| 12/1/2015 | 21SGT03FIG (SUBTROPICAL AND TROPICAL FRUIT) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 9/21/2007 | 21VCT14TAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 249FILTHY | Florida District Office (FLA-DO) |
| 8/31/2004 | 21DYT01FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES | New Orleans District Office (NOL-DO) | |
| 7/2/2004 | 21SEE24PALM NUT (PALM FRUIT, SUGAR PALM) (SUBTROPICAL AND TROPICAL FRUIT) | 83NO PROCESS | Florida District Office (FLA-DO) |
| 6/2/2004 | 25JET16CASSAVA (ROOT AND TUBER VEGETABLE) | 83NO PROCESS | Florida District Office (FLA-DO) |
| 5/3/2004 | 25NCE99ROOT & TUBER VEGETABLE, WITH SAUCE, N.E.C. | Florida District Office (FLA-DO) | |
| 5/3/2004 | 21UCE03FIG, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | Florida District Office (FLA-DO) | |
| 5/3/2004 | 21UEE03FIG, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is C.I. Dona Paula S.A.'s FDA import refusal history?
C.I. Dona Paula S.A. (FEI: 3004296257) has 8 FDA import refusal record(s) in our database, spanning from 5/3/2004 to 12/1/2015.
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. C.I. Dona Paula S.A.'s FEI number is 3004296257.
What types of violations has C.I. Dona Paula S.A. received?
C.I. Dona Paula S.A. has been cited for 5 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 C.I. Dona Paula S.A. come from?
All FDA import refusal data for C.I. Dona Paula 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.