ImportRefusal LogoImportRefusal

Syn-Tech Chemical & Pharm. Co., Ltd.

⚠️ Moderate Risk

FEI: 3002808302 • Tainan City • TAIWAN

FEI

FEI Number

3002808302

📍

Location

Tainan City

🇹🇼

Country

TAIWAN
🏢

Address

168 Kaiyuan Rd., Xinying Dist., Tainan City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

48.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/19/2025
Latest Refusal
12/9/2004
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
66.9×20%
Frequency
1.0×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
2/19/2025
60LQT71XYLAZINE HCL (ANALGESIC)
72NEW VET DR
Division of Northern Border Imports (DNBI)
12/9/2004
60QAS69PRAMOXINE HCL (ANESTHETIC)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Syn-Tech Chemical & Pharm. Co., Ltd.'s FDA import refusal history?

Syn-Tech Chemical & Pharm. Co., Ltd. (FEI: 3002808302) has 2 FDA import refusal record(s) in our database, spanning from 12/9/2004 to 2/19/2025.

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. Syn-Tech Chemical & Pharm. Co., Ltd.'s FEI number is 3002808302.

What types of violations has Syn-Tech Chemical & Pharm. Co., Ltd. received?

Syn-Tech Chemical & Pharm. 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 Syn-Tech Chemical & Pharm. Co., Ltd. come from?

All FDA import refusal data for Syn-Tech Chemical & Pharm. 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.