Novartis Consumer Health S.A.
⚠️ Moderate Risk
FEI: 3004809965 • Barcelona, Barcelona • SPAIN
FEI Number
3004809965
Location
Barcelona, Barcelona
Country
SPAINAddress
Gran Via de Les Corts Catalanes 764, , Barcelona, Barcelona, Spain
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 3/12/2018 | 61PDA99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/1/2016 | 62OBA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/19/2008 | 62ORA15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | New Orleans District Office (NOL-DO) | |
| 7/24/2006 | 62GBB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/28/2005 | 61NDA99ANTI-DEPRESSANT N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
| 5/27/2004 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2004 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/24/2002 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novartis Consumer Health S.A.'s FDA import refusal history?
Novartis Consumer Health S.A. (FEI: 3004809965) has 8 FDA import refusal record(s) in our database, spanning from 7/24/2002 to 3/12/2018.
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 Consumer Health S.A.'s FEI number is 3004809965.
What types of violations has Novartis Consumer Health S.A. received?
Novartis Consumer Health S.A. has been cited for 5 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 Consumer Health S.A. come from?
All FDA import refusal data for Novartis Consumer Health 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.