Zhejiang Guobang Pharmaceutical Co., Ltd
⚠️ High Risk
FEI: 3008617115 • Shaoxing, Zhejiang • CHINA
FEI Number
3008617115
Location
Shaoxing, Zhejiang
Country
CHINAAddress
Hangzhou Gulf Shangyu Economic, No 6 Weiwu Road; And Technological Development Zone, Shaoxing, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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.
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.
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 |
|---|---|---|---|
| 2/16/2024 | 56ICR76AZITHROMYCIN (MACAROLIDES) | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 5/16/2022 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of West Coast Imports (DWCI) | |
| 5/11/2016 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2016 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2016 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2016 | 61FAB56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2016 | 56OCT05ENROFLOXACIN (FLUOROQUINOLONE) | 3280FRNMFGREG | San Francisco District Office (SAN-DO) |
| 1/24/2014 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2013 | 61GRR47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Zhejiang Guobang Pharmaceutical Co., Ltd's FDA import refusal history?
Zhejiang Guobang Pharmaceutical Co., Ltd (FEI: 3008617115) has 9 FDA import refusal record(s) in our database, spanning from 4/15/2013 to 2/16/2024.
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 Guobang Pharmaceutical Co., Ltd's FEI number is 3008617115.
What types of violations has Zhejiang Guobang Pharmaceutical Co., Ltd received?
Zhejiang Guobang 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 Zhejiang Guobang Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Zhejiang Guobang 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.