Hebei Huarong Pharmaceutical Co.,Ltd
⚠️ Moderate Risk
FEI: 3004252894 • Shijiazhuang, Hebei • CHINA
FEI Number
3004252894
Location
Shijiazhuang, Hebei
Country
CHINAAddress
East Road North 2nd Circle, , 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
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
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 |
|---|---|---|---|
| 9/8/2021 | 54ABR11HYDROXOCOBALAMIN (VITAMIN) | Division of Northern Border Imports (DNBI) | |
| 9/13/2017 | 54ABY05VITAMIN B12 (CYANOCOBALAMIN) | 3560SUPPL GMP | Division of Southeast Imports (DSEI) |
| 12/18/2015 | 64ECZ99ENZYME N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/4/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hebei Huarong Pharmaceutical Co.,Ltd's FDA import refusal history?
Hebei Huarong Pharmaceutical Co.,Ltd (FEI: 3004252894) has 4 FDA import refusal record(s) in our database, spanning from 1/4/2012 to 9/8/2021.
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 Huarong Pharmaceutical Co.,Ltd's FEI number is 3004252894.
What types of violations has Hebei Huarong Pharmaceutical Co.,Ltd received?
Hebei Huarong Pharmaceutical Co.,Ltd 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 Hebei Huarong Pharmaceutical Co.,Ltd come from?
All FDA import refusal data for Hebei Huarong Pharmaceutical 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.