Parexel Ukraine Llc
⚠️ Moderate Risk
FEI: 3007926189 • Kyiv, Kyiv • UKRAINE
FEI Number
3007926189
Location
Kyiv, Kyiv
Country
UKRAINEAddress
9 Moskovskiy Pr, , Kyiv, Kyiv, Ukraine
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
Frequently Asked Questions
What is Parexel Ukraine Llc's FDA import refusal history?
Parexel Ukraine Llc (FEI: 3007926189) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2009 to 12/15/2009.
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. Parexel Ukraine Llc's FEI number is 3007926189.
What types of violations has Parexel Ukraine Llc received?
Parexel Ukraine Llc 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 Parexel Ukraine Llc come from?
All FDA import refusal data for Parexel Ukraine Llc 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.