SYNECCO CO. LTD.
⚠️ Moderate Risk
FEI: 3008713077 • Ningbo, Zhejiang • CHINA
FEI Number
3008713077
Location
Ningbo, Zhejiang
Country
CHINAAddress
Rongan Plaza B801, No. 700 South Tiantong Road; Yinzhou District, Ningbo, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/25/2019 | 78FPDTUBE, FEEDING | Division of West Coast Imports (DWCI) | |
| 9/25/2019 | 78FPDTUBE, FEEDING | Division of West Coast Imports (DWCI) | |
| 4/12/2019 | 80FMFSYRINGE, PISTON | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SYNECCO CO. LTD.'s FDA import refusal history?
SYNECCO CO. LTD. (FEI: 3008713077) has 3 FDA import refusal record(s) in our database, spanning from 4/12/2019 to 9/25/2019.
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. SYNECCO CO. LTD.'s FEI number is 3008713077.
What types of violations has SYNECCO CO. LTD. received?
SYNECCO CO. LTD. has been cited for 6 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 SYNECCO CO. LTD. come from?
All FDA import refusal data for SYNECCO 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.