Concord Manufacturing Inc
⚠️ Moderate Risk
FEI: 3004417541 • Kaohsiung • TAIWAN
FEI Number
3004417541
Location
Kaohsiung
Country
TAIWANAddress
142 Hua Mei Rd, , Kaohsiung, , 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
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).
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.
Refusal History
Frequently Asked Questions
What is Concord Manufacturing Inc's FDA import refusal history?
Concord Manufacturing Inc (FEI: 3004417541) has 1 FDA import refusal record(s) in our database, spanning from 8/26/2004 to 8/26/2004.
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. Concord Manufacturing Inc's FEI number is 3004417541.
What types of violations has Concord Manufacturing Inc received?
Concord Manufacturing Inc has been cited for 2 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 Concord Manufacturing Inc come from?
All FDA import refusal data for Concord Manufacturing Inc 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.