NOVARTIS FARMACEUTICA SA
⚠️ Moderate Risk
FEI: 3012455616 • Mexico Df • MEXICO
FEI Number
3012455616
Location
Mexico Df
Country
MEXICOAddress
Calzada de Tlalpan 1779, , Mexico Df, , Mexico
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2023 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2020 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 62LDA20HYDROXYSTILBAMIDINE ISETHIONATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARI | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 60LCA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2017 | 62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2017 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 3/31/2017 | 60QDO07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NOVARTIS FARMACEUTICA SA's FDA import refusal history?
NOVARTIS FARMACEUTICA SA (FEI: 3012455616) has 7 FDA import refusal record(s) in our database, spanning from 3/31/2017 to 2/1/2023.
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 FARMACEUTICA SA's FEI number is 3012455616.
What types of violations has NOVARTIS FARMACEUTICA SA received?
NOVARTIS FARMACEUTICA SA 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 NOVARTIS FARMACEUTICA SA come from?
All FDA import refusal data for NOVARTIS FARMACEUTICA SA 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.