Guangzhou Light Industrial Import Export Corp
⚠️ Moderate Risk
FEI: 1000209951 • Guangzhou, Guangdong • CHINA
FEI Number
1000209951
Location
Guangzhou, Guangdong
Country
CHINAAddress
No 87 The Bund, , 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 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2007 | 79MRDSIZER, MAMMARY, BREAST IMPLANT VOLUME | 508NO 510(K) | Florida District Office (FLA-DO) |
| 2/17/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | San Francisco District Office (SAN-DO) | |
| 2/17/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | San Francisco District Office (SAN-DO) | |
| 2/17/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Guangzhou Light Industrial Import Export Corp's FDA import refusal history?
Guangzhou Light Industrial Import Export Corp (FEI: 1000209951) has 4 FDA import refusal record(s) in our database, spanning from 2/17/2007 to 5/29/2007.
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. Guangzhou Light Industrial Import Export Corp's FEI number is 1000209951.
What types of violations has Guangzhou Light Industrial Import Export Corp received?
Guangzhou Light Industrial Import Export Corp 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 Guangzhou Light Industrial Import Export Corp come from?
All FDA import refusal data for Guangzhou Light Industrial Import Export Corp 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.