Phibro Saude Animal Internacional Ltda.
⚠️ Moderate Risk
FEI: 3003286077 • Guarulhos, Sao Paulo • BRAZIL
FEI Number
3003286077
Location
Guarulhos, Sao Paulo
Country
BRAZILAddress
Avenida Presidente Tancredo De Almeida Neves, , Guarulhos, 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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2011 | 56YJS99ANTIBIOTIC N.E.C. | Chicago District Office (CHI-DO) | |
| 2/7/2011 | 56YJS99ANTIBIOTIC N.E.C. | Chicago District Office (CHI-DO) | |
| 8/24/2010 | 56YYR99ANTIBIOTIC N.E.C. | Chicago District Office (CHI-DO) | |
| 8/24/2010 | 56LXS85VIRGINIAMYCIN (NON-CERTIFIABLE) | Chicago District Office (CHI-DO) | |
| 8/24/2010 | 56LXS85VIRGINIAMYCIN (NON-CERTIFIABLE) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Phibro Saude Animal Internacional Ltda.'s FDA import refusal history?
Phibro Saude Animal Internacional Ltda. (FEI: 3003286077) has 5 FDA import refusal record(s) in our database, spanning from 8/24/2010 to 2/7/2011.
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. Phibro Saude Animal Internacional Ltda.'s FEI number is 3003286077.
What types of violations has Phibro Saude Animal Internacional Ltda. received?
Phibro Saude Animal Internacional 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 Phibro Saude Animal Internacional Ltda. come from?
All FDA import refusal data for Phibro Saude Animal Internacional 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.