SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP
⚠️ Moderate Risk
FEI: 3012662722 • Vila Velha, Espirito Santo • BRAZIL
FEI Number
3012662722
Location
Vila Velha, Espirito Santo
Country
BRAZILAddress
Rua Haroldo Lobo 99, , Vila Velha, Espirito Santo, 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
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/28/2020 | 85HISCONDOM | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 7/10/2019 | 33AGT05CANDY BARS OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)(WITHOUT | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP's FDA import refusal history?
SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP (FEI: 3012662722) has 3 FDA import refusal record(s) in our database, spanning from 7/10/2019 to 12/22/2020.
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. SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP's FEI number is 3012662722.
What types of violations has SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP received?
SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP has been cited for 4 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 SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP come from?
All FDA import refusal data for SEA OLIMPIC IMPORTACAO E EXPORTACAO EIRELI EPP 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.