Fougera Pharmaceuticals Inc.
⚠️ Moderate Risk
FEI: 2432435 • Melville, NY • UNITED STATES
FEI Number
2432435
Location
Melville, NY
Country
UNITED STATESAddress
60 Baylis Rd, , Melville, 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.
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2012 | 56ICO10ERYTHROMYCIN (MACROLIDES) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 56ICO10ERYTHROMYCIN (MACROLIDES) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 4/6/2012 | 66SDJ28NITROGLYCERIN (TAB) (VASODILATOR) | Division of Southeast Imports (DSEI) | |
| 8/21/2009 | 64LDY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 12/16/2008 | 80KMJLUBRICANT, PATIENT | Seattle District Office (SEA-DO) | |
| 11/21/2008 | 80KMJLUBRICANT, PATIENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 12/14/2007 | 64LDK03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/11/2007 | 61WDJ31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Fougera Pharmaceuticals Inc.'s FDA import refusal history?
Fougera Pharmaceuticals Inc. (FEI: 2432435) has 8 FDA import refusal record(s) in our database, spanning from 7/11/2007 to 9/11/2012.
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. Fougera Pharmaceuticals Inc.'s FEI number is 2432435.
What types of violations has Fougera Pharmaceuticals Inc. received?
Fougera Pharmaceuticals 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 Fougera Pharmaceuticals Inc. come from?
All FDA import refusal data for Fougera 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.