Chongqing Derma Optic and Electronic Technique Co., Ltd.
⚠️ Moderate Risk
FEI: 3010168388 • Chongqing, Chongqing • CHINA
FEI Number
3010168388
Location
Chongqing, Chongqing
Country
CHINAAddress
Biological & Biochemical Park F 2 # 70, Th Road; Hi-Tech Zone, Chongqing, Chongqing, 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 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.
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Southeast Imports (DSEI) | |
| 11/14/2014 | 95RHHLED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL PRODUCTS, NON-MEDICAL | Division of Southeast Imports (DSEI) | |
| 7/18/2013 | 79OAPLASER, COMB, HAIR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Chongqing Derma Optic and Electronic Technique Co., Ltd.'s FDA import refusal history?
Chongqing Derma Optic and Electronic Technique Co., Ltd. (FEI: 3010168388) has 3 FDA import refusal record(s) in our database, spanning from 7/18/2013 to 12/15/2014.
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. Chongqing Derma Optic and Electronic Technique Co., Ltd.'s FEI number is 3010168388.
What types of violations has Chongqing Derma Optic and Electronic Technique Co., Ltd. received?
Chongqing Derma Optic and Electronic Technique 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 Chongqing Derma Optic and Electronic Technique Co., Ltd. come from?
All FDA import refusal data for Chongqing Derma Optic and Electronic Technique 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.