Jiangsu Lianhuan Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3004026935 • Yangzhou, Jiangsu • CHINA
FEI Number
3004026935
Location
Yangzhou, Jiangsu
Country
CHINAAddress
Biological Health Industrial Park, 9 Jiankangyi Road, Yangzhou, Jiangsu, 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
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.
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).
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.
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 |
|---|---|---|---|
| 9/1/2017 | 56EDA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2015 | 61XCZ34TERFENADINE (ANTI-HISTAMINIC) | New Orleans District Office (NOL-DO) | |
| 10/26/2015 | 56ECT21DOXYCYCLINE MONOHYDRATE (TETRACYCLINES) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 7/15/2015 | 56EJS22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 72NEW VET DR | Detroit District Office (DET-DO) |
| 9/3/2013 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/1/2013 | 56EDR21DOXYCYCLINE MONOHYDRATE (TETRACYCLINES) | San Francisco District Office (SAN-DO) | |
| 6/11/2013 | 56EDT21DOXYCYCLINE MONOHYDRATE (TETRACYCLINES) | 16DIRECTIONS | San Francisco District Office (SAN-DO) |
| 5/15/2012 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/17/2012 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 5/18/2011 | 66BCS99STIMULANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/18/2011 | 66BCS99STIMULANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 6/24/2010 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/13/2009 | 66BCS99STIMULANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/31/2002 | 56GAR99ANTIFUNGAL N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/31/2002 | 61TCS99ANTI-EMETIC/NAUSEANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jiangsu Lianhuan Pharmaceutical Co., Ltd's FDA import refusal history?
Jiangsu Lianhuan Pharmaceutical Co., Ltd (FEI: 3004026935) has 15 FDA import refusal record(s) in our database, spanning from 7/31/2002 to 9/1/2017.
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. Jiangsu Lianhuan Pharmaceutical Co., Ltd's FEI number is 3004026935.
What types of violations has Jiangsu Lianhuan Pharmaceutical Co., Ltd received?
Jiangsu Lianhuan 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 Jiangsu Lianhuan Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Jiangsu Lianhuan 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.