Tzong Rong Optical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003430382 • Guangzhou, Guangdong • CHINA
FEI Number
3003430382
Location
Guangzhou, Guangdong
Country
CHINAAddress
Shihling Town, 107 Country Road, West; Shilingzhen Huadou District, Guangzhou, Guangdong, 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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Seattle District Office (SEA-DO) | |
| 5/17/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Cincinnati District Office (CIN-DO) | |
| 5/17/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Cincinnati District Office (CIN-DO) | |
| 8/2/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 2/16/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Southwest Import District Office (SWI-DO) |
| 10/2/2001 | 86HOISPECTACLE, MAGNIFYING | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Tzong Rong Optical Co., Ltd.'s FDA import refusal history?
Tzong Rong Optical Co., Ltd. (FEI: 3003430382) has 6 FDA import refusal record(s) in our database, spanning from 10/2/2001 to 6/15/2012.
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. Tzong Rong Optical Co., Ltd.'s FEI number is 3003430382.
What types of violations has Tzong Rong Optical Co., Ltd. received?
Tzong Rong Optical Co., Ltd. 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 Tzong Rong Optical Co., Ltd. come from?
All FDA import refusal data for Tzong Rong Optical 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.