Libbs Farmaceutica Ltda
⚠️ High Risk
FEI: 3007993641 • Embu, Sp • BRAZIL
FEI Number
3007993641
Location
Embu, Sp
Country
BRAZILAddress
R Alberto Correa Frankfort 8, , Embu, Sp, Brazil
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2025 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 61NDY64VILOXAZINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 64TDA08TACROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2011 | 64GDB27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Libbs Farmaceutica Ltda's FDA import refusal history?
Libbs Farmaceutica Ltda (FEI: 3007993641) has 6 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 8/14/2025.
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. Libbs Farmaceutica Ltda's FEI number is 3007993641.
What types of violations has Libbs Farmaceutica Ltda received?
Libbs Farmaceutica Ltda has been cited for 2 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 Libbs Farmaceutica Ltda come from?
All FDA import refusal data for Libbs Farmaceutica 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.