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Root Chemical Pharmacy Co Ltd

⚠️ Moderate Risk

FEI: 3007738895 • Ta Chia Cheng • TAIWAN

FEI

FEI Number

3007738895

📍

Location

Ta Chia Cheng

🇹🇼

Country

TAIWAN
🏢

Address

13 Nan Pei 1 Rd, , Ta Chia Cheng, , Taiwan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/2/2009
Latest Refusal
9/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
9/2/2009
62VCO18ACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Root Chemical Pharmacy Co Ltd's FDA import refusal history?

Root Chemical Pharmacy Co Ltd (FEI: 3007738895) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2009 to 9/2/2009.

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. Root Chemical Pharmacy Co Ltd's FEI number is 3007738895.

What types of violations has Root Chemical Pharmacy Co Ltd received?

Root Chemical Pharmacy Co Ltd 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 Root Chemical Pharmacy Co Ltd come from?

All FDA import refusal data for Root Chemical Pharmacy 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.