TENDA ATACADO LTDA.
⚠️ Moderate Risk
FEI: 3013210229 • Guarulhos, Sao Paulo • BRAZIL
FEI Number
3013210229
Location
Guarulhos, Sao Paulo
Country
BRAZILAddress
Rua Professor Joao Cavaleiro Salem 365, , Guarulhos, Sao Paulo, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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)).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2010 | 30YFY02COCONUT MILK BEVERAGE BASE | Florida District Office (FLA-DO) | |
| 6/17/2010 | 33KGY05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 5/1/2006 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is TENDA ATACADO LTDA.'s FDA import refusal history?
TENDA ATACADO LTDA. (FEI: 3013210229) has 3 FDA import refusal record(s) in our database, spanning from 5/1/2006 to 6/17/2010.
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. TENDA ATACADO LTDA.'s FEI number is 3013210229.
What types of violations has TENDA ATACADO LTDA. received?
TENDA ATACADO 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 TENDA ATACADO LTDA. come from?
All FDA import refusal data for TENDA ATACADO 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.