ImportRefusal LogoImportRefusal

Tyson Bioresearch Inc.

⚠️ Moderate Risk

FEI: 3003132490 • Miaoli County, Zhunan Township • TAIWAN

FEI

FEI Number

3003132490

📍

Location

Miaoli County, Zhunan Township

🇹🇼

Country

TAIWAN
🏢

Address

Science Based Industrial Park, 5f., No. 16, 18, 20, 22, Kedong 3rd Rd., Miaoli County, Zhunan Township, Taiwan

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
8/21/2002
Latest Refusal
8/21/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5085×

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.

Refusal History

DateProductViolationsDivision
8/21/2002
76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
8/21/2002
74DXQCUFF, BLOOD-PRESSURE
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
8/21/2002
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
8/21/2002
81KQEASSAY, ERYTHROCYTIC GLUCOSE-6-PHOSPHATE DEHYDROGENASE
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
8/21/2002
81LJXTEST, URINE LEUKOCYTE
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Tyson Bioresearch Inc.'s FDA import refusal history?

Tyson Bioresearch Inc. (FEI: 3003132490) has 5 FDA import refusal record(s) in our database, spanning from 8/21/2002 to 8/21/2002.

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. Tyson Bioresearch Inc.'s FEI number is 3003132490.

What types of violations has Tyson Bioresearch Inc. received?

Tyson Bioresearch Inc. 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 Tyson Bioresearch Inc. come from?

All FDA import refusal data for Tyson Bioresearch Inc. 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.