Linhai City Tiantian Glasses Mfg
✅ Low Risk
FEI: 3010392525 • Taizhou Linhai City • CHINA
FEI Number
3010392525
Location
Taizhou Linhai City
Country
CHINAAddress
3-10 Lu Jia Village Du Qiao, , Taizhou Linhai City, , China
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
Frequently Asked Questions
What is Linhai City Tiantian Glasses Mfg's FDA import refusal history?
Linhai City Tiantian Glasses Mfg (FEI: 3010392525) has 1 FDA import refusal record(s) in our database, spanning from 10/8/2013 to 10/8/2013.
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. Linhai City Tiantian Glasses Mfg's FEI number is 3010392525.
What types of violations has Linhai City Tiantian Glasses Mfg received?
Linhai City Tiantian Glasses Mfg 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 Linhai City Tiantian Glasses Mfg come from?
All FDA import refusal data for Linhai City Tiantian Glasses Mfg 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.