Novartis Consumer Health C/O Ohl
⚠️ Moderate Risk
FEI: 3008431877 • Plainfield, IN • UNITED STATES
FEI Number
3008431877
Location
Plainfield, IN
Country
UNITED STATESAddress
1101 Whitaker Rd, , Plainfield, IN, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2010 | 66CAH99STOOL SOFTENER N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAZ99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAZ99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60SAY99ANTACID, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 66CAH99STOOL SOFTENER N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAZ99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60LAZ99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60SAY99ANTACID, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 53LC04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60SAK99ANTACID, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 54BYY07IRON (MINERAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 60SAY99ANTACID, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 66CAH99STOOL SOFTENER N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 66CAH99STOOL SOFTENER N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 66CAH99STOOL SOFTENER N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Novartis Consumer Health C/O Ohl's FDA import refusal history?
Novartis Consumer Health C/O Ohl (FEI: 3008431877) has 17 FDA import refusal record(s) in our database, spanning from 9/22/2010 to 9/22/2010.
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 C/O Ohl's FEI number is 3008431877.
What types of violations has Novartis Consumer Health C/O Ohl received?
Novartis Consumer Health C/O Ohl has been cited for 1 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 C/O Ohl come from?
All FDA import refusal data for Novartis Consumer Health C/O Ohl 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.