Shanghai Lei Yun Shang Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003447230 • Shanghai, Shanghai • CHINA
FEI Number
3003447230
Location
Shanghai, Shanghai
Country
CHINAAddress
320 Hangyi Road, Fengxian, Shanghai, Shanghai, 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
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.
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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
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 |
|---|---|---|---|
| 10/2/2006 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2200DIET INGRE | Los Angeles District Office (LOS-DO) |
| 9/18/2006 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 7/12/2006 | 54FAH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 7/12/2006 | 54FYC99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 6/7/2006 | 54FAH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 10/18/2005 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 6/16/2005 | 54FAT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 6/3/2004 | 54FAN99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Lei Yun Shang Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shanghai Lei Yun Shang Pharmaceutical Co., Ltd. (FEI: 3003447230) has 8 FDA import refusal record(s) in our database, spanning from 6/3/2004 to 10/2/2006.
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. Shanghai Lei Yun Shang Pharmaceutical Co., Ltd.'s FEI number is 3003447230.
What types of violations has Shanghai Lei Yun Shang Pharmaceutical Co., Ltd. received?
Shanghai Lei Yun Shang 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 Shanghai Lei Yun Shang Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shanghai Lei Yun Shang 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.