Bayonne Alimentos
⚠️ Moderate Risk
FEI: 3005281847 • Curitiba, Parana • BRAZIL
FEI Number
3005281847
Location
Curitiba, Parana
Country
BRAZILAddress
Rua Paul Garfunkel, 455, , Curitiba, Parana, 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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 |
|---|---|---|---|
| 8/5/2011 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 8/5/2011 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 41EGE99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 2/8/2007 | 41EGE99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 9/25/2006 | 41EGE99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Bayonne Alimentos's FDA import refusal history?
Bayonne Alimentos (FEI: 3005281847) has 15 FDA import refusal record(s) in our database, spanning from 9/25/2006 to 8/5/2011.
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. Bayonne Alimentos's FEI number is 3005281847.
What types of violations has Bayonne Alimentos received?
Bayonne Alimentos has been cited for 7 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 Bayonne Alimentos come from?
All FDA import refusal data for Bayonne Alimentos 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.