South America Import Ltda
⚠️ Moderate Risk
FEI: 3003339927 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3003339927
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Dona Leopoldina 427, , Sao Paulo, 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
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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)).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 4/5/2005 | 60QBJ56BENZOCAINE (ANESTHETIC) | San Francisco District Office (SAN-DO) | |
| 2/25/2005 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | San Francisco District Office (SAN-DO) |
| 11/4/2004 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 11/4/2004 | 76JESFLOSS, DENTAL | New York District Office (NYK-DO) | |
| 11/4/2004 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 11/4/2004 | 85HHDPAD, MENSTRUAL, UNSCENTED | New York District Office (NYK-DO) | |
| 10/28/2004 | 85HHDPAD, MENSTRUAL, UNSCENTED | New York District Office (NYK-DO) | |
| 12/22/2003 | 60SAA15MAGNESIUM PHOSPHATE (ANTACID) | San Francisco District Office (SAN-DO) | |
| 5/23/2003 | 85HISCONDOM | New York District Office (NYK-DO) |
Frequently Asked Questions
What is South America Import Ltda's FDA import refusal history?
South America Import Ltda (FEI: 3003339927) has 9 FDA import refusal record(s) in our database, spanning from 5/23/2003 to 4/5/2005.
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. South America Import Ltda's FEI number is 3003339927.
What types of violations has South America Import Ltda received?
South America Import Ltda has been cited for 9 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 South America Import Ltda come from?
All FDA import refusal data for South America Import 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.