Sunsho Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004668319 • Fujinomiya, Shizuoka • JAPAN
FEI Number
3004668319
Location
Fujinomiya, Shizuoka
Country
JAPANAddress
533-2, Oiwa, Fujinomiya, Shizuoka, Japan
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).
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.
UNSFDIETUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
Refusal History
Frequently Asked Questions
What is Sunsho Pharmaceutical Co., Ltd.'s FDA import refusal history?
Sunsho Pharmaceutical Co., Ltd. (FEI: 3004668319) has 2 FDA import refusal record(s) in our database, spanning from 7/24/2013 to 1/11/2016.
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. Sunsho Pharmaceutical Co., Ltd.'s FEI number is 3004668319.
What types of violations has Sunsho Pharmaceutical Co., Ltd. received?
Sunsho 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 Sunsho Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Sunsho 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.