Uniflora Nutraceutica Ltda.
⚠️ Moderate Risk
FEI: 2000001102 • Olimpia, Sao Paulo • BRAZIL
FEI Number
2000001102
Location
Olimpia, Sao Paulo
Country
BRAZILAddress
1117 Bela Vista Street, , Olimpia, 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
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2019 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2016 | 54GBL99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | Florida District Office (FLA-DO) | |
| 10/20/2011 | 77KCOINHALER, NASAL | Florida District Office (FLA-DO) | |
| 8/5/2010 | 54GBL99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/31/2004 | 54YCL06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 488HEALTH C | Florida District Office (FLA-DO) |
| 8/31/2004 | 54YCL06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 488HEALTH C | Florida District Office (FLA-DO) |
| 5/27/2004 | 28CCT99NATURAL EXTRACT OR FLAVOR, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Uniflora Nutraceutica Ltda.'s FDA import refusal history?
Uniflora Nutraceutica Ltda. (FEI: 2000001102) has 7 FDA import refusal record(s) in our database, spanning from 5/27/2004 to 12/19/2019.
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. Uniflora Nutraceutica Ltda.'s FEI number is 2000001102.
What types of violations has Uniflora Nutraceutica Ltda. received?
Uniflora Nutraceutica Ltda. 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 Uniflora Nutraceutica Ltda. come from?
All FDA import refusal data for Uniflora Nutraceutica 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.