Hebei Huari Pharmaceuticals Co Ltd
⚠️ Moderate Risk
FEI: 3002952855 • Shijiazhuang, Hebei • CHINA
FEI Number
3002952855
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Shijiazhuang Economic Technical Zone, 8 Xingye Street, Shijiazhuang, Hebei, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2007 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/5/2007 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/26/2007 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/2/2006 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 9/20/2006 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/7/2006 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 5/4/2006 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/13/2005 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/24/2005 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/9/2005 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/9/2004 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 11/30/2004 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 9/1/2004 | 56AXS10PENICILLIN G, NATURAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/9/2004 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hebei Huari Pharmaceuticals Co Ltd's FDA import refusal history?
Hebei Huari Pharmaceuticals Co Ltd (FEI: 3002952855) has 14 FDA import refusal record(s) in our database, spanning from 3/9/2004 to 12/12/2007.
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. Hebei Huari Pharmaceuticals Co Ltd's FEI number is 3002952855.
What types of violations has Hebei Huari Pharmaceuticals Co Ltd received?
Hebei Huari Pharmaceuticals Co Ltd has been cited for 3 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 Hebei Huari Pharmaceuticals Co Ltd come from?
All FDA import refusal data for Hebei Huari Pharmaceuticals 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.