Epitomics

⚠️ High Risk

FEI: 3008287986 • Hangzhou • CHINA

FEI

FEI Number

3008287986

📍

Location

Hangzhou

🇨🇳

Country

CHINA

🏢

Address

1418 Mo Gan Shan Rd, , Hangzhou, , China

High Risk

FDA Import Risk Assessment

54.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

9/19/2018

Latest Refusal

9/7/2018

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

68.1×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

22368×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

Date	Product	Violations	Division
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57VH99IN-VITRO DIAG PRODUCTS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/19/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)
9/7/2018	88OTURESEARCH USE ONLY/PATHOLOGY	223FALSE	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Epitomics's FDA import refusal history?

Epitomics (FEI: 3008287986) has 68 FDA import refusal record(s) in our database, spanning from 9/7/2018 to 9/19/2018.

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. Epitomics's FEI number is 3008287986.

What types of violations has Epitomics received?

Epitomics 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 Epitomics come from?

All FDA import refusal data for Epitomics 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.