Zhejiang Ruibang Laboratories Co., Ltd
⚠️ Moderate Risk
FEI: 3001027745 • Wenzhou, Zhejiang • CHINA
FEI Number
3001027745
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Economic, 578 Binhai Ten Road; Longwan, Wenzhou, 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2013 | 62GDY89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/18/2012 | 62GCZ89CYCLOSPORINE (ANTI-INFLAMMATORY) | San Francisco District Office (SAN-DO) | |
| 12/11/2006 | 56KIR99MISCELLANEOUS ANTIBIOTICS, N.E.C. | Detroit District Office (DET-DO) | |
| 7/3/2002 | 62GBZ89CYCLOSPORINE (ANTI-INFLAMMATORY) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Zhejiang Ruibang Laboratories Co., Ltd's FDA import refusal history?
Zhejiang Ruibang Laboratories Co., Ltd (FEI: 3001027745) has 4 FDA import refusal record(s) in our database, spanning from 7/3/2002 to 6/11/2013.
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 Ruibang Laboratories Co., Ltd's FEI number is 3001027745.
What types of violations has Zhejiang Ruibang Laboratories Co., Ltd received?
Zhejiang Ruibang Laboratories Co., Ltd has been cited for 6 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 Ruibang Laboratories Co., Ltd come from?
All FDA import refusal data for Zhejiang Ruibang Laboratories 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.