Zhejiang Hisun Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3007719313 • Taizhou, Zhejiang • CHINA
FEI Number
3007719313
Location
Taizhou, Zhejiang
Country
CHINAAddress
46 Waisha Rd., Jiaojiang District, 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
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).
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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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).
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2017 | 60KNS16ZERANOL (ANABOLIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 4/25/2016 | 61JIS12LOVASTATIN (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 5/21/2015 | 62LCR47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Los Angeles District Office (LOS-DO) | |
| 5/13/2015 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/19/2014 | 54YBZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/24/2014 | 66VBP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 10/22/2012 | 56HDR45MITOMYCIN (ANTITUMOR) | San Francisco District Office (SAN-DO) | |
| 10/17/2012 | 68BCR99OTHER ANIMAL, N.E.C. ANTI-INFECTIVE | 72NEW VET DR | Philadelphia District Office (PHI-DO) |
| 8/16/2011 | 56YCS99ANTIBIOTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 4/24/2008 | 60LDZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/24/2008 | 60LDZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Zhejiang Hisun Pharmaceutical Co., Ltd.'s FDA import refusal history?
Zhejiang Hisun Pharmaceutical Co., Ltd. (FEI: 3007719313) has 11 FDA import refusal record(s) in our database, spanning from 4/24/2008 to 3/29/2017.
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. Zhejiang Hisun Pharmaceutical Co., Ltd.'s FEI number is 3007719313.
What types of violations has Zhejiang Hisun Pharmaceutical Co., Ltd. received?
Zhejiang Hisun Pharmaceutical Co., Ltd. has been cited for 7 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 Hisun Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Zhejiang Hisun 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.