Pure Herbs International Trading Limited
⚠️ Moderate Risk
FEI: 3004126711 • Hong Kong • HONG KONG
FEI Number
3004126711
Location
Hong Kong
Country
HONG KONGAddress
Room 805, Pacific Place II, 88 Queensway, Hong Kong, , Hong Kong
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2004 | 60RBA99ANOREXIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/29/2004 | 64GBA99ESTROGEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/29/2004 | 60RBJ99ANOREXIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/29/2004 | 60RBA99ANOREXIC, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Pure Herbs International Trading Limited's FDA import refusal history?
Pure Herbs International Trading Limited (FEI: 3004126711) has 4 FDA import refusal record(s) in our database, spanning from 7/29/2004 to 7/29/2004.
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. Pure Herbs International Trading Limited's FEI number is 3004126711.
What types of violations has Pure Herbs International Trading Limited received?
Pure Herbs International Trading Limited has been cited for 5 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 Pure Herbs International Trading Limited come from?
All FDA import refusal data for Pure Herbs International Trading Limited 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.