Quintiles Laboratories Ltd
✅ Low Risk
FEI: 3009457028 • Centurion, Northern Region • SOUTH AFRICA
FEI Number
3009457028
Location
Centurion, Northern Region
Country
SOUTH AFRICAAddress
125 Amkor Road, , Centurion, Northern Region, South Africa
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2012 | 88LDTREAGENT, GENERAL PURPOSE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Quintiles Laboratories Ltd's FDA import refusal history?
Quintiles Laboratories Ltd (FEI: 3009457028) has 1 FDA import refusal record(s) in our database, spanning from 8/6/2012 to 8/6/2012.
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. Quintiles Laboratories Ltd's FEI number is 3009457028.
What types of violations has Quintiles Laboratories Ltd received?
Quintiles Laboratories 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 Quintiles Laboratories Ltd come from?
All FDA import refusal data for Quintiles Laboratories 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.