Jiangsu NHWA Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3005619485 • Xuzhou, Jiangsu • CHINA
FEI Number
3005619485
Location
Xuzhou, Jiangsu
Country
CHINAAddress
Industrial Park, No. 6 Tianyong Road; Jiawang District, Xuzhou, 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
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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
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 |
|---|---|---|---|
| 5/4/2018 | 61NQT11CLOMIPRAMINE HCL (ANTI-DEPRESSANT) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 12/17/2014 | 61WAZ44ECONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 10/28/2005 | 66MIY09BUSPIRONE HCL (TRANQUILIZER) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Jiangsu NHWA Pharmaceutical Co., Ltd.'s FDA import refusal history?
Jiangsu NHWA Pharmaceutical Co., Ltd. (FEI: 3005619485) has 3 FDA import refusal record(s) in our database, spanning from 10/28/2005 to 5/4/2018.
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 NHWA Pharmaceutical Co., Ltd.'s FEI number is 3005619485.
What types of violations has Jiangsu NHWA Pharmaceutical Co., Ltd. received?
Jiangsu NHWA Pharmaceutical 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 Jiangsu NHWA Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Jiangsu NHWA 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.