Linhai Tianma Glasses Factory
⚠️ Moderate Risk
FEI: 3009549392 • Linhai • CHINA
FEI Number
3009549392
Location
Linhai
Country
CHINAAddress
5-88 Henglou Village Duqiao Town, , Linhai, , 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
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 1/3/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 10/24/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 10/22/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) | |
| 10/8/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) | |
| 10/4/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Linhai Tianma Glasses Factory's FDA import refusal history?
Linhai Tianma Glasses Factory (FEI: 3009549392) has 7 FDA import refusal record(s) in our database, spanning from 10/4/2013 to 1/22/2014.
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 Tianma Glasses Factory's FEI number is 3009549392.
What types of violations has Linhai Tianma Glasses Factory received?
Linhai Tianma Glasses Factory has been cited for 5 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 Tianma Glasses Factory come from?
All FDA import refusal data for Linhai Tianma Glasses Factory 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.