Beijing Kowloon Pharmaceutical Factory
⚠️ Moderate Risk
FEI: 3003880203 • Beijing • CHINA
FEI Number
3003880203
Location
Beijing
Country
CHINAAddress
No 1200 Diyang Bldg, , Beijing, , China
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
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).
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).
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.
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 |
|---|---|---|---|
| 3/20/2017 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | Southwest Import District Office (SWI-DO) | |
| 10/3/2005 | 66SCA51TADALAFIL | San Francisco District Office (SAN-DO) | |
| 4/8/2005 | 66SDA51TADALAFIL | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2004 | 60NBA99ANDROGEN, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Beijing Kowloon Pharmaceutical Factory's FDA import refusal history?
Beijing Kowloon Pharmaceutical Factory (FEI: 3003880203) has 4 FDA import refusal record(s) in our database, spanning from 7/29/2004 to 3/20/2017.
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. Beijing Kowloon Pharmaceutical Factory's FEI number is 3003880203.
What types of violations has Beijing Kowloon Pharmaceutical Factory received?
Beijing Kowloon Pharmaceutical Factory has been cited for 4 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 Beijing Kowloon Pharmaceutical Factory come from?
All FDA import refusal data for Beijing Kowloon Pharmaceutical Factory 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.