Wuhan Gigaa Optronics Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3010287651 • Wuhan, Hubei • CHINA
FEI Number
3010287651
Location
Wuhan, Hubei
Country
CHINAAddress
B8-A5, Wuhan Hi-Tech Medical Device Park, # 818 Gaoxin Avenue; Hongshan, Wuhan, Hubei, 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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.
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).
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2017 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 4/20/2016 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) | |
| 9/14/2015 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 9/11/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 8/16/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 7/5/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Cincinnati District Office (CIN-DO) | |
| 12/9/2011 | 95RGBVETERINARY LASER, IN VITRO AND OTHER MEDICAL LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 11/25/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wuhan Gigaa Optronics Technology Co., Ltd.'s FDA import refusal history?
Wuhan Gigaa Optronics Technology Co., Ltd. (FEI: 3010287651) has 9 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 9/13/2017.
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. Wuhan Gigaa Optronics Technology Co., Ltd.'s FEI number is 3010287651.
What types of violations has Wuhan Gigaa Optronics Technology Co., Ltd. received?
Wuhan Gigaa Optronics Technology Co., Ltd. has been cited for 8 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 Wuhan Gigaa Optronics Technology Co., Ltd. come from?
All FDA import refusal data for Wuhan Gigaa Optronics Technology 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.