Ancheng Pharma Limited
⚠️ Moderate Risk
FEI: 3006409304 • Sheung Wan, Hong Kong • HONG KONG
FEI Number
3006409304
Location
Sheung Wan, Hong Kong
Country
HONG KONGAddress
Rm B, 6/F, Teda Bldg, Sheung Wan, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2012 | 56YJR99ANTIBIOTIC N.E.C. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 4/5/2012 | 68YAR20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 9/27/2007 | 61JBZ11GEMFIBROZIL (ANTI-CHOLESTEREMIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Ancheng Pharma Limited's FDA import refusal history?
Ancheng Pharma Limited (FEI: 3006409304) has 3 FDA import refusal record(s) in our database, spanning from 9/27/2007 to 4/5/2012.
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. Ancheng Pharma Limited's FEI number is 3006409304.
What types of violations has Ancheng Pharma Limited received?
Ancheng Pharma Limited 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 Ancheng Pharma Limited come from?
All FDA import refusal data for Ancheng Pharma 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.