Guang Shing Gmt Fty
⚠️ Moderate Risk
FEI: 1000412720 • Guangzhou • CHINA
FEI Number
1000412720
Location
Guangzhou
Country
CHINAAddress
Blk 1 Fong Yuen Sai Po Ind Estate Wong, , Guangzhou, , 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 4/4/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Guang Shing Gmt Fty's FDA import refusal history?
Guang Shing Gmt Fty (FEI: 1000412720) has 6 FDA import refusal record(s) in our database, spanning from 4/4/2011 to 4/4/2011.
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. Guang Shing Gmt Fty's FEI number is 1000412720.
What types of violations has Guang Shing Gmt Fty received?
Guang Shing Gmt Fty 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 Guang Shing Gmt Fty come from?
All FDA import refusal data for Guang Shing Gmt Fty 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.