Novartis Consumer Health S.A.
⚠️ Moderate Risk
FEI: 3002583778 • Nyon 2, Vaud • SWITZERLAND
FEI Number
3002583778
Location
Nyon 2, Vaud
Country
SWITZERLANDAddress
Case Postale 269, , Nyon 2, Vaud, Switzerland
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 |
|---|---|---|---|
| 11/15/2016 | 62GCJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 10/28/2011 | 66VDO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 60CDK53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/2/2010 | 60CBK09PHENYLEPHRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 12/2/2010 | 60CCK09PHENYLEPHRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 12/2/2010 | 60CBO09PHENYLEPHRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 5/27/2008 | 60CCQ53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 60CBK53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/4/2007 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/10/2006 | 60LCJ99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2005 | 60QIQ40LIDOCAINE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 1/18/2005 | 61NDA99ANTI-DEPRESSANT N.E.C. | 342PERSONALRX | 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: 3002583778) has 12 FDA import refusal record(s) in our database, spanning from 1/18/2005 to 11/15/2016.
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 Consumer Health S.A.'s FEI number is 3002583778.
What types of violations has Novartis Consumer Health S.A. received?
Novartis Consumer Health S.A. has been cited for 4 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.