I.S.I. Importacao E Exportacao Ltda,
⚠️ Moderate Risk
FEI: 3003129611 • Rio de Janeiro, Rio de Janeiro • BRAZIL
FEI Number
3003129611
Location
Rio de Janeiro, Rio de Janeiro
Country
BRAZILAddress
Rua Sargento Aquino 531 S 101, , Rio de Janeiro, Rio de Janeiro, Brazil
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
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.
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.
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)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2002 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 12/4/2002 | 29BET01SOFT DRINK, BERRY FRUIT FLAVORED, CARBONATED | Florida District Office (FLA-DO) | |
| 12/4/2002 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/4/2002 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/11/2002 | 21XCF03FIG (SUBTROPICAL/TROPICAL FRUIT PULP) | Florida District Office (FLA-DO) | |
| 7/11/2002 | 21GCF14PLUM (PIT FRUIT) | Florida District Office (FLA-DO) | |
| 4/10/2002 | 09EHO05MILK, FLAVORED, NON FAT | Florida District Office (FLA-DO) | |
| 10/17/2001 | 60SBZ09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/17/2001 | 60SBZ09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is I.S.I. Importacao E Exportacao Ltda,'s FDA import refusal history?
I.S.I. Importacao E Exportacao Ltda, (FEI: 3003129611) has 9 FDA import refusal record(s) in our database, spanning from 10/17/2001 to 12/4/2002.
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. I.S.I. Importacao E Exportacao Ltda,'s FEI number is 3003129611.
What types of violations has I.S.I. Importacao E Exportacao Ltda, received?
I.S.I. Importacao E Exportacao Ltda, has been cited for 6 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 I.S.I. Importacao E Exportacao Ltda, come from?
All FDA import refusal data for I.S.I. Importacao E Exportacao Ltda, 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.