Hebei Jiheng Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004803368 • Hengshui, Hebei • CHINA
FEI Number
3004803368
Location
Hengshui, Hebei
Country
CHINAAddress
Hengshui Industrial Park, 1 Weiwu Street, Hengshui, 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).
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.
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 |
|---|---|---|---|
| 3/24/2014 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 3/24/2014 | 64XBR06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 11/21/2006 | 60LCS21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Hebei Jiheng Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hebei Jiheng Pharmaceutical Co., Ltd. (FEI: 3004803368) has 3 FDA import refusal record(s) in our database, spanning from 11/21/2006 to 3/24/2014.
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 Jiheng Pharmaceutical Co., Ltd.'s FEI number is 3004803368.
What types of violations has Hebei Jiheng Pharmaceutical Co., Ltd. received?
Hebei Jiheng Pharmaceutical 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 Jiheng Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hebei Jiheng 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.