Novartis Biociencias S.A.
⚠️ High Risk
FEI: 3000245736 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3000245736
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Avenida Professor Vicente Rao 90, , Sao Paulo, Sao Paulo, 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 |
|---|---|---|---|
| 12/29/2023 | 66BCY19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/20/2022 | 62ODY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2012 | 65UBA02TRIBENOSIDE (SCLEROSING AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2012 | 60KAA12PIZOTYLINE (ANABOLIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/10/2012 | 56KCO10CHLORAMPHENICOL | Florida District Office (FLA-DO) | |
| 12/20/2011 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 62GCB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2008 | 62BCY08PIMETINE HCL (ANTI-HYPERLIPIDEMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novartis Biociencias S.A.'s FDA import refusal history?
Novartis Biociencias S.A. (FEI: 3000245736) has 9 FDA import refusal record(s) in our database, spanning from 9/22/2008 to 12/29/2023.
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. Novartis Biociencias S.A.'s FEI number is 3000245736.
What types of violations has Novartis Biociencias S.A. received?
Novartis Biociencias S.A. 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 Novartis Biociencias S.A. come from?
All FDA import refusal data for Novartis Biociencias S.A. 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.