E&J Galvanirua Joao Pessoa
⚠️ Moderate Risk
FEI: 3004518755 • Santos • 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
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)).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/10/2004 | 16AEN33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 24VCT39HEART OF PALM, WITH SAUCE | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 36ACT09MAPLE SUGAR | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 30YCT02COCONUT MILK BEVERAGE BASE | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 14BET07IMITATION MILK, CONCENTRATED, EVAPORATED MILK TYPE PRODUCT | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 21SET03FIG (SUBTROPICAL AND TROPICAL FRUIT) | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 14YET99FILLED OR IMITATION MILK OR MILK TYPE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 30YCT02COCONUT MILK BEVERAGE BASE | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 22KCT99OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 14YET99FILLED OR IMITATION MILK OR MILK TYPE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/22/2004 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is E&J Galvanirua Joao Pessoa's FDA import refusal history?
E&J Galvanirua Joao Pessoa (FEI: 3004518755) has 11 FDA import refusal record(s) in our database, spanning from 7/22/2004 to 10/10/2004.
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. E&J Galvanirua Joao Pessoa's FEI number is 3004518755.
What types of violations has E&J Galvanirua Joao Pessoa received?
E&J Galvanirua Joao Pessoa 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 E&J Galvanirua Joao Pessoa come from?
All FDA import refusal data for E&J Galvanirua Joao Pessoa 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.