Hunan Dongting Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004753289 • Changde, Hunan • CHINA
FEI Number
3004753289
Location
Changde, Hunan
Country
CHINAAddress
16 Dong Yan Road, Deshan Kaifa, Changde, Hunan, 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
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.
Refusal History
Frequently Asked Questions
What is Hunan Dongting Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hunan Dongting Pharmaceutical Co., Ltd. (FEI: 3004753289) has 2 FDA import refusal record(s) in our database, spanning from 5/12/2009 to 1/28/2011.
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. Hunan Dongting Pharmaceutical Co., Ltd.'s FEI number is 3004753289.
What types of violations has Hunan Dongting Pharmaceutical Co., Ltd. received?
Hunan Dongting Pharmaceutical Co., Ltd. has been cited for 2 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 Hunan Dongting Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hunan Dongting 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.