Zhejiang Hisoar Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3003735151 • Taizhou, Zhejiang • CHINA
FEI Number
3003735151
Location
Taizhou, Zhejiang
Country
CHINAAddress
100 Waisha Branch Road, Jiaojiang, Taizhou, Zhejiang, 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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 |
|---|---|---|---|
| 11/17/2016 | 56JDR31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 2280DIRSEXMPT | Atlanta District Office (ATL-DO) |
| 5/17/2011 | 56JCS22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/26/2007 | 62GIS37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zhejiang Hisoar Pharmaceutical Co. Ltd.'s FDA import refusal history?
Zhejiang Hisoar Pharmaceutical Co. Ltd. (FEI: 3003735151) has 3 FDA import refusal record(s) in our database, spanning from 7/26/2007 to 11/17/2016.
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. Zhejiang Hisoar Pharmaceutical Co. Ltd.'s FEI number is 3003735151.
What types of violations has Zhejiang Hisoar Pharmaceutical Co. Ltd. received?
Zhejiang Hisoar 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 Zhejiang Hisoar Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Zhejiang Hisoar 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.