Sandoz Inc
⚠️ Moderate Risk
FEI: 3011552892 • Princeton, NJ • UNITED STATES
FEI Number
3011552892
Location
Princeton, NJ
Country
UNITED STATESAddress
100 College Rd W, , Princeton, NJ, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 3/22/2023 | 60XDO23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 61TDA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56ODA02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 61FDA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 61NDA05BUPROPION HCL (ANTI-DEPRESSANT) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56BDH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56DCH06AMIKACIN SULFATE (AMINOGLYCOSIDES) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 6/15/2020 | 64LCA44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/21/2016 | 62ODC12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sandoz Inc's FDA import refusal history?
Sandoz Inc (FEI: 3011552892) has 9 FDA import refusal record(s) in our database, spanning from 9/21/2016 to 3/22/2023.
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. Sandoz Inc's FEI number is 3011552892.
What types of violations has Sandoz Inc received?
Sandoz Inc has been cited for 2 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 Sandoz Inc come from?
All FDA import refusal data for Sandoz 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.