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D.C. BOTANICAL BIOTECHNOLOGY CO. LTD.

⚠️ Moderate Risk

FEI: 3005057570 • Taipei, Taipei - Special Municipality • TAIWAN

FEI

FEI Number

3005057570

📍

Location

Taipei, Taipei - Special Municipality

🇹🇼

Country

TAIWAN
🏢

Address

2 Fl, Banchiun City, Taipei, Taipei - Special Municipality, Taiwan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/26/2007
Latest Refusal
7/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1181×

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).

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
3/26/2007
66VBZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
7/1/2006
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is D.C. BOTANICAL BIOTECHNOLOGY CO. LTD.'s FDA import refusal history?

D.C. BOTANICAL BIOTECHNOLOGY CO. LTD. (FEI: 3005057570) has 2 FDA import refusal record(s) in our database, spanning from 7/1/2006 to 3/26/2007.

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. D.C. BOTANICAL BIOTECHNOLOGY CO. LTD.'s FEI number is 3005057570.

What types of violations has D.C. BOTANICAL BIOTECHNOLOGY CO. LTD. received?

D.C. BOTANICAL 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 D.C. BOTANICAL BIOTECHNOLOGY CO. LTD. come from?

All FDA import refusal data for D.C. BOTANICAL 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.