Botupharma Industria e Comercio de Produtos Veterinarios Ltda.
⚠️ Moderate Risk
FEI: 3010291201 • Botucatu, Sao Paulo • BRAZIL
FEI Number
3010291201
Location
Botucatu, Sao Paulo
Country
BRAZILAddress
Rua Coronel Fonseca, 2111, , Botucatu, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2017 | 68XDY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 5/17/2017 | 68XDY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 5/17/2017 | 68XDY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 5/17/2017 | 68YDL02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 4/9/2015 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 3260NO ENGLISH | Cincinnati District Office (CIN-DO) |
| 4/9/2015 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 238UNSAFE ADD | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Botupharma Industria e Comercio de Produtos Veterinarios Ltda.'s FDA import refusal history?
Botupharma Industria e Comercio de Produtos Veterinarios Ltda. (FEI: 3010291201) has 6 FDA import refusal record(s) in our database, spanning from 4/9/2015 to 5/17/2017.
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. Botupharma Industria e Comercio de Produtos Veterinarios Ltda.'s FEI number is 3010291201.
What types of violations has Botupharma Industria e Comercio de Produtos Veterinarios Ltda. received?
Botupharma Industria e Comercio de Produtos Veterinarios Ltda. has been cited for 3 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 Botupharma Industria e Comercio de Produtos Veterinarios Ltda. come from?
All FDA import refusal data for Botupharma Industria e Comercio de Produtos Veterinarios 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.