Hoffman Exportacao E Comercio De Cosmeticos Ltda
⚠️ Moderate Risk
FEI: 3004781109 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3004781109
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Vieira de Morais 1290 Sala 04, , 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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 2/10/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Florida District Office (FLA-DO) | |
| 7/15/2005 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Florida District Office (FLA-DO) | |
| 7/15/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Hoffman Exportacao E Comercio De Cosmeticos Ltda's FDA import refusal history?
Hoffman Exportacao E Comercio De Cosmeticos Ltda (FEI: 3004781109) has 3 FDA import refusal record(s) in our database, spanning from 7/15/2005 to 2/10/2006.
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. Hoffman Exportacao E Comercio De Cosmeticos Ltda's FEI number is 3004781109.
What types of violations has Hoffman Exportacao E Comercio De Cosmeticos Ltda received?
Hoffman Exportacao E Comercio De Cosmeticos Ltda has been cited for 5 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 Hoffman Exportacao E Comercio De Cosmeticos Ltda come from?
All FDA import refusal data for Hoffman Exportacao E Comercio De Cosmeticos 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.