Hebei Kangning Co Ltd
⚠️ Moderate Risk
FEI: 3007500091 • Shijiazhuang • CHINA
FEI Number
3007500091
Location
Shijiazhuang
Country
CHINAAddress
302-5-5#, No. 58 Guotai Street, , Shijiazhuang, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56ECA22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56BCK10BENZYLPENICILLOYL-POLYLYSINE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hebei Kangning Co Ltd's FDA import refusal history?
Hebei Kangning Co Ltd (FEI: 3007500091) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2017 to 3/24/2017.
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. Hebei Kangning Co Ltd's FEI number is 3007500091.
What types of violations has Hebei Kangning Co Ltd received?
Hebei Kangning Co Ltd has been cited for 2 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 Kangning Co Ltd come from?
All FDA import refusal data for Hebei Kangning 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.