Novartis Consumer Health S.A.
⚠️ Moderate Risk
FEI: 3008480552 • Nyon, Vaud • SWITZERLAND
FEI Number
3008480552
Location
Nyon, Vaud
Country
SWITZERLANDAddress
Route De L'Etraz 2, , Nyon, 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
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2023 | 62GCJ90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2021 | 61XBQ50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 8/24/2021 | 61XBQ50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 12/30/2020 | 66FAJ99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 61XBL99ANTI-HISTAMINIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 60CAL53XYLOMETAZOLINE HCL (ADRENERGIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Novartis Consumer Health S.A.'s FDA import refusal history?
Novartis Consumer Health S.A. (FEI: 3008480552) has 6 FDA import refusal record(s) in our database, spanning from 5/22/2017 to 6/28/2023.
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 Consumer Health S.A.'s FEI number is 3008480552.
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.