Pharmaron Manufacturing Services (UK) Ltd.
⚠️ Moderate Risk
FEI: 3002806562 • Cramlington, Northumberland • UNITED KINGDOM
FEI Number
3002806562
Location
Cramlington, Northumberland
Country
UNITED KINGDOMAddress
Windmill Industrial Estate, Shotton Lane, Cramlington, Northumberland, United Kingdom
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2018 | 60TCS14NALOXONE HCL (ANTAGONIST) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/4/2018 | 60TCS14NALOXONE HCL (ANTAGONIST) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/29/2015 | 60TIR14NALOXONE HCL (ANTAGONIST) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Pharmaron Manufacturing Services (UK) Ltd.'s FDA import refusal history?
Pharmaron Manufacturing Services (UK) Ltd. (FEI: 3002806562) has 3 FDA import refusal record(s) in our database, spanning from 6/29/2015 to 5/4/2018.
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. Pharmaron Manufacturing Services (UK) Ltd.'s FEI number is 3002806562.
What types of violations has Pharmaron Manufacturing Services (UK) Ltd. received?
Pharmaron Manufacturing Services (UK) Ltd. 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 Pharmaron Manufacturing Services (UK) Ltd. come from?
All FDA import refusal data for Pharmaron Manufacturing Services (UK) Ltd. 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.