Novartis Consumer Health Inc.
⚠️ High Risk
FEI: 2244859 • Parsippany, NJ • UNITED STATES
FEI Number
2244859
Location
Parsippany, NJ
Country
UNITED STATESAddress
200 Kimball Dr, , Parsippany, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2019 | 63HAY23SENNOSIDES A AND B (CATHARTIC) | Division of Northern Border Imports (DNBI) | |
| 11/13/2014 | 62OCB12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/14/2013 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2011 | 60LBZ01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60LBR01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60QAJ34DIBUCAINE (ANESTHETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 66BAE05CAFFEINE (STIMULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 62MAJ08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60SBL14MAGNESIUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 61VAA01SIMETHICONE (ANTI-FLATULENT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2011 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/19/2011 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/16/2011 | 66BAA05CAFFEINE (STIMULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 66BAA05CAFFEINE (STIMULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60LOJ99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/11/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/31/2011 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/7/2011 | 60SBA04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/7/2011 | 60SBA04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 66BAA05CAFFEINE (STIMULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60LBC01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60LBC01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60LBA63SALICYLAMIDE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 61VBL01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 61VBL01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 60SBL04ALUMINUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/28/2010 | 63HBA23SENNOSIDES A AND B (CATHARTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/9/2010 | 60CBL49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/15/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/15/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/15/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/4/2010 | 60LBR01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/4/2010 | 62MAJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/4/2010 | 60LAE66SODIUM SALICYLATE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/27/2007 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/27/2007 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Novartis Consumer Health Inc.'s FDA import refusal history?
Novartis Consumer Health Inc. (FEI: 2244859) has 64 FDA import refusal record(s) in our database, spanning from 8/27/2007 to 10/17/2019.
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 Inc.'s FEI number is 2244859.
What types of violations has Novartis Consumer Health Inc. received?
Novartis Consumer Health Inc. 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 Inc. come from?
All FDA import refusal data for Novartis Consumer Health Inc. 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.