Zhejiang Langhua Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3005289386 • Linhai, Zheijiang • CHINA
FEI Number
3005289386
Location
Linhai, Zheijiang
Country
CHINAAddress
No 7 Donghai 3 Avenue, Zhejiang Provincial And Medic, Linhai, Zheijiang, 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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/3/2014 | 56OCT05ENROFLOXACIN (FLUOROQUINOLONE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/4/2013 | 56OJT05ENROFLOXACIN (FLUOROQUINOLONE) | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 6/11/2013 | 62OCB15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/9/2010 | 64BAS37SPIRONOLACTONE (DIURETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/14/2008 | 61GAS84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Zhejiang Langhua Pharmaceutical Co. Ltd.'s FDA import refusal history?
Zhejiang Langhua Pharmaceutical Co. Ltd. (FEI: 3005289386) has 5 FDA import refusal record(s) in our database, spanning from 10/14/2008 to 2/3/2014.
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 Langhua Pharmaceutical Co. Ltd.'s FEI number is 3005289386.
What types of violations has Zhejiang Langhua Pharmaceutical Co. Ltd. received?
Zhejiang Langhua Pharmaceutical Co. Ltd. has been cited for 4 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 Langhua Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Zhejiang Langhua 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.