ImportRefusal LogoImportRefusal

HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD

⚠️ Moderate Risk

FEI: 3016670527 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3016670527

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Building 1 2nd Floor, Pingyaozhen Yuhang District, Hangzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

10
Total Refusals
2
Unique Violations
7/28/2020
Latest Refusal
5/26/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
38.6×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

50810×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

24803×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
7/28/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
508NO 510(K)
Division of Southeast Imports (DSEI)
7/28/2020
83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
508NO 510(K)
Division of Southeast Imports (DSEI)
6/11/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
2480RXPERSONAL
508NO 510(K)
Division of Southeast Imports (DSEI)
6/11/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
2480RXPERSONAL
508NO 510(K)
Division of Southeast Imports (DSEI)
6/11/2020
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
508NO 510(K)
Division of Northern Border Imports (DNBI)
6/11/2020
77KCMDROPPER, ENT
508NO 510(K)
Division of Northern Border Imports (DNBI)
6/11/2020
81GIFDILUENT, BLOOD CELL
508NO 510(K)
Division of Northern Border Imports (DNBI)
6/11/2020
81GIFDILUENT, BLOOD CELL
508NO 510(K)
Division of Northern Border Imports (DNBI)
6/11/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
508NO 510(K)
Division of Northern Border Imports (DNBI)
5/26/2020
83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
2480RXPERSONAL
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD's FDA import refusal history?

HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD (FEI: 3016670527) has 10 FDA import refusal record(s) in our database, spanning from 5/26/2020 to 7/28/2020.

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. HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD's FEI number is 3016670527.

What types of violations has HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD received?

HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD 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 HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD come from?

All FDA import refusal data for HANGZHOU TESTSEA BIOTECHNOLOGY CO 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.