Sndz Overseas Co., Ltd.
✅ Low Risk
FEI: 3003528117 • Taipei • TAIWAN
FEI Number
3003528117
Location
Taipei
Country
TAIWANAddress
6th Floor, 118 Chung Cheng Rd. Shih, , Taipei, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Sndz Overseas Co., Ltd.'s FDA import refusal history?
Sndz Overseas Co., Ltd. (FEI: 3003528117) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2006 to 4/11/2006.
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. Sndz Overseas Co., Ltd.'s FEI number is 3003528117.
What types of violations has Sndz Overseas Co., Ltd. received?
Sndz Overseas 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 Sndz Overseas Co., Ltd. come from?
All FDA import refusal data for Sndz Overseas 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.