Novartis Farmaceutica S.A. De C.V.
⚠️ Moderate Risk
FEI: 3001743983 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3001743983
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Calzada De Tlalpan 1779, Col. San Diego Churubusco, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/29/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/7/2011 | 60QCY07LIDOCAINE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/13/2008 | 62UIM01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/6/2008 | 60LCA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/15/2008 | 62GQC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 9/7/2007 | 62ODA06RESERPINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2007 | 61SCY04PIMECROLIMUS | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/3/2007 | 64LDJ37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/10/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2007 | 64FDY15BROMOCRIPTINE (ENZYME INHIBITOR) | New Orleans District Office (NOL-DO) | |
| 11/4/2005 | 61WCB52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 62OBC44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 61JQY10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/2/2005 | 61WCP52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/12/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Novartis Farmaceutica S.A. De C.V.'s FDA import refusal history?
Novartis Farmaceutica S.A. De C.V. (FEI: 3001743983) has 18 FDA import refusal record(s) in our database, spanning from 10/12/2004 to 6/8/2016.
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 S.A. De C.V.'s FEI number is 3001743983.
What types of violations has Novartis Farmaceutica S.A. De C.V. received?
Novartis Farmaceutica S.A. De C.V. has been cited for 8 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 S.A. De C.V. come from?
All FDA import refusal data for Novartis Farmaceutica S.A. De C.V. 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.