Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
⚠️ Moderate Risk
FEI: 1719513 • Tarrytown, NY • UNITED STATES
FEI Number
1719513
Location
Tarrytown, NY
Country
UNITED STATESAddress
660 White Plains Rd Ste 250, , Tarrytown, 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
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 |
|---|---|---|---|
| 1/10/2007 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/10/2007 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/19/2006 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/19/2006 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 56EBK81TETRACYCLINE HYDROCHLORIDE (TETRACYCLINES) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 60CBY57PSEUDOEPHEDRINE (ADRENERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company's FDA import refusal history?
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company (FEI: 1719513) has 7 FDA import refusal record(s) in our database, spanning from 8/18/2006 to 1/10/2007.
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. Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company's FEI number is 1719513.
What types of violations has Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company received?
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 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 Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company come from?
All FDA import refusal data for Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 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.