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PuraPharm International (H.K.) Ltd.

⚠️ Moderate Risk

FEI: 3010012749 • Central, Hong Kong Island • HONG KONG

FEI

FEI Number

3010012749

📍

Location

Central, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Suite 4002, 1 Connaught Place, Central, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/13/2006
Latest Refusal
11/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

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
11/13/2006
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/13/2006
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is PuraPharm International (H.K.) Ltd.'s FDA import refusal history?

PuraPharm International (H.K.) Ltd. (FEI: 3010012749) has 2 FDA import refusal record(s) in our database, spanning from 11/13/2006 to 11/13/2006.

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. PuraPharm International (H.K.) Ltd.'s FEI number is 3010012749.

What types of violations has PuraPharm International (H.K.) Ltd. received?

PuraPharm International (H.K.) 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 PuraPharm International (H.K.) Ltd. come from?

All FDA import refusal data for PuraPharm International (H.K.) 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.