PHARBACO CENTRAL PHARMACEUTICAL
⚠️ Moderate Risk
FEI: 3020790645 • Hanoi • VIETNAM
FEI Number
3020790645
Location
Hanoi
Country
VIETNAMAddress
No 160, Ton Duc Thang St, , Hanoi, , Vietnam
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 PHARBACO CENTRAL PHARMACEUTICAL's FDA import refusal history?
PHARBACO CENTRAL PHARMACEUTICAL (FEI: 3020790645) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2021 to 12/13/2021.
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. PHARBACO CENTRAL PHARMACEUTICAL's FEI number is 3020790645.
What types of violations has PHARBACO CENTRAL PHARMACEUTICAL received?
PHARBACO CENTRAL PHARMACEUTICAL 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 PHARBACO CENTRAL PHARMACEUTICAL come from?
All FDA import refusal data for PHARBACO CENTRAL PHARMACEUTICAL 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.