Roche Pharmaceuticals
⚠️ Moderate Risk
FEI: 3000508362 • Nutley, NJ • UNITED STATES
FEI Number
3000508362
Location
Nutley, NJ
Country
UNITED STATESAddress
340 Kingsland St, , Nutley, 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
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).
Refusal History
Frequently Asked Questions
What is Roche Pharmaceuticals's FDA import refusal history?
Roche Pharmaceuticals (FEI: 3000508362) has 2 FDA import refusal record(s) in our database, spanning from 6/5/2006 to 10/17/2009.
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. Roche Pharmaceuticals's FEI number is 3000508362.
What types of violations has Roche Pharmaceuticals received?
Roche Pharmaceuticals 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 Roche Pharmaceuticals come from?
All FDA import refusal data for Roche Pharmaceuticals 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.