GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO
⚠️ Moderate Risk
FEI: 3009875911 • Shantou, Guangdong • CHINA
FEI Number
3009875911
Location
Shantou, Guangdong
Country
CHINAAddress
Guanghai Building F/6, Changping Road, Shantou, 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).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/2/2014 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/2/2014 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/2/2014 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO's FDA import refusal history?
GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO (FEI: 3009875911) has 4 FDA import refusal record(s) in our database, spanning from 9/2/2014 to 9/2/2014.
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. GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO's FEI number is 3009875911.
What types of violations has GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO received?
GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO has been cited for 7 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 GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO come from?
All FDA import refusal data for GUANGDONG SHANTOU AQUATIC PRODUCTS IMP/EXP CO 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.