Delta Synthetic Co., Ltd.
⚠️ Moderate Risk
FEI: 1545 • New Taipei City • TAIWAN
FEI Number
1545
Location
New Taipei City
Country
TAIWANAddress
15 Minsheng St, Tucheng Dist., New Taipei City, , Taiwan
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
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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 |
|---|---|---|---|
| 2/25/2022 | 60QAS07LIDOCAINE | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 8/17/2016 | 64HAS02GUAIFENESIN (EXPECTORANT) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/23/2014 | 60QCY40LIDOCAINE HCL (ANESTHETIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 8/28/2013 | 60QAY40LIDOCAINE HCL (ANESTHETIC) | Los Angeles District Office (LOS-DO) | |
| 7/15/2013 | 60QBS40LIDOCAINE HCL (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/1/2013 | 60QAS67LIDOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 7/1/2013 | 60QAS40LIDOCAINE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 2/15/2013 | 60QAY40LIDOCAINE HCL (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/29/2010 | 64HCR02GUAIFENESIN (EXPECTORANT) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Delta Synthetic Co., Ltd.'s FDA import refusal history?
Delta Synthetic Co., Ltd. (FEI: 1545) has 9 FDA import refusal record(s) in our database, spanning from 9/29/2010 to 2/25/2022.
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. Delta Synthetic Co., Ltd.'s FEI number is 1545.
What types of violations has Delta Synthetic Co., Ltd. received?
Delta Synthetic 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 Delta Synthetic Co., Ltd. come from?
All FDA import refusal data for Delta Synthetic 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.