Schering-Plough Employee Health Services
⚠️ Moderate Risk
FEI: 1000527091 • Kenilworth, NJ • UNITED STATES
FEI Number
1000527091
Location
Kenilworth, NJ
Country
UNITED STATESAddress
2000 Galloping Hill Rd, , Kenilworth, 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
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 |
|---|---|---|---|
| 7/26/2021 | 64LCY03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2017 | 64MDY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2016 | 64GDB27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Schering-Plough Employee Health Services's FDA import refusal history?
Schering-Plough Employee Health Services (FEI: 1000527091) has 3 FDA import refusal record(s) in our database, spanning from 11/2/2016 to 7/26/2021.
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. Schering-Plough Employee Health Services's FEI number is 1000527091.
What types of violations has Schering-Plough Employee Health Services received?
Schering-Plough Employee Health Services 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 Schering-Plough Employee Health Services come from?
All FDA import refusal data for Schering-Plough Employee Health Services 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.