Zhucheng Haotian Pharm Co. Ltd.
⚠️ Moderate Risk
FEI: 3006785507 • Weifang, Shandong • CHINA
FEI Number
3006785507
Location
Weifang, Shandong
Country
CHINAAddress
64 Jiangjun Road, Xinxing Town, Weifang, Shandong, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2015 | 66S40INOSITOL NIACINATE (VASODILATOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/15/2007 | 66SPR40INOSITOL NIACINATE (VASODILATOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/16/2006 | 66SCS40INOSITOL NIACINATE (VASODILATOR) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Zhucheng Haotian Pharm Co. Ltd.'s FDA import refusal history?
Zhucheng Haotian Pharm Co. Ltd. (FEI: 3006785507) has 3 FDA import refusal record(s) in our database, spanning from 11/16/2006 to 6/25/2015.
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. Zhucheng Haotian Pharm Co. Ltd.'s FEI number is 3006785507.
What types of violations has Zhucheng Haotian Pharm Co. Ltd. received?
Zhucheng Haotian Pharm 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 Zhucheng Haotian Pharm Co. Ltd. come from?
All FDA import refusal data for Zhucheng Haotian Pharm 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.