Strides Pharma, Inc.
⚠️ Moderate Risk
FEI: 2434223 • Chestnut Ridge, NY • UNITED STATES
FEI Number
2434223
Location
Chestnut Ridge, NY
Country
UNITED STATESAddress
1 Ram Ridge Rd, , Chestnut Ridge, 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
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.
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 |
|---|---|---|---|
| 11/25/2019 | 65DCK06OXYTOCIN (INJECTION) (OXYTOCIC) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 8/16/2016 | 61NDY05BUPROPION HCL (ANTI-DEPRESSANT) | 179AGR RX | New York District Office (NYK-DO) |
| 4/29/2015 | 62OBA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/21/2009 | 60SDA22FAMOTIDINE (ANTACID) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 11/24/2003 | 64LCA19DEXAMETHASONE (GLUCOCORTICOID) | 179AGR RX | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Strides Pharma, Inc.'s FDA import refusal history?
Strides Pharma, Inc. (FEI: 2434223) has 5 FDA import refusal record(s) in our database, spanning from 11/24/2003 to 11/25/2019.
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. Strides Pharma, Inc.'s FEI number is 2434223.
What types of violations has Strides Pharma, Inc. received?
Strides Pharma, 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 Strides Pharma, Inc. come from?
All FDA import refusal data for Strides Pharma, 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.