Sanofi-Winthrop Pharmaceuticals, Inc.
⚠️ Moderate Risk
FEI: 3002744163 • New York, NY • UNITED STATES
FEI Number
3002744163
Location
New York, NY
Country
UNITED STATESAddress
90 Park Ave, , New York, NY, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2007 | 62LDA33PRIMAQUINE PHOSPHATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 10/4/2005 | 62CCB65LISINOPRIL (ANTI-HYPERTENSIVE) | 179AGR RX | San Francisco District Office (SAN-DO) |
| 7/19/2005 | 78MRESOLUTION, SODIUM HYALURONATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi-Winthrop Pharmaceuticals, Inc.'s FDA import refusal history?
Sanofi-Winthrop Pharmaceuticals, Inc. (FEI: 3002744163) has 3 FDA import refusal record(s) in our database, spanning from 7/19/2005 to 7/31/2007.
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. Sanofi-Winthrop Pharmaceuticals, Inc.'s FEI number is 3002744163.
What types of violations has Sanofi-Winthrop Pharmaceuticals, Inc. received?
Sanofi-Winthrop Pharmaceuticals, Inc. has been cited for 3 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 Sanofi-Winthrop Pharmaceuticals, Inc. come from?
All FDA import refusal data for Sanofi-Winthrop Pharmaceuticals, 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.