Zhejiang Xianju Junye Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004072297 • Taizhou, Zhejiang • CHINA
FEI Number
3004072297
Location
Taizhou, Zhejiang
Country
CHINAAddress
Modern Industrial, No. 1 Lingxiu Road; Xianjuxian, Taizhou, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
ANDRO
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2005 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | Division of Southeast Imports (DSEI) |
| 9/8/2004 | 60NAY14TESTOSTERONE (ANDROGEN) | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 9/7/2004 | 60NAY14TESTOSTERONE (ANDROGEN) | 2460UNSFDIETLB | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zhejiang Xianju Junye Pharmaceutical Co., Ltd.'s FDA import refusal history?
Zhejiang Xianju Junye Pharmaceutical Co., Ltd. (FEI: 3004072297) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2004 to 1/5/2005.
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 Xianju Junye Pharmaceutical Co., Ltd.'s FEI number is 3004072297.
What types of violations has Zhejiang Xianju Junye Pharmaceutical Co., Ltd. received?
Zhejiang Xianju Junye Pharmaceutical Co., Ltd. has been cited for 3 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 Xianju Junye Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Zhejiang Xianju Junye 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.