Suzhou Linhua Plastic Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3002803561 • Suzhou, Jiangsu • CHINA
FEI Number
3002803561
Location
Suzhou, Jiangsu
Country
CHINAAddress
Eastern Suburbs Of Mudu Suzhou, , Suzhou, Jiangsu, 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
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.
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 |
|---|---|---|---|
| 6/20/2011 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 6/20/2011 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 6/20/2011 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 6/20/2011 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 10/15/2005 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/6/2004 | 79JCYCATHETER, INFUSION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Suzhou Linhua Plastic Products Co., Ltd.'s FDA import refusal history?
Suzhou Linhua Plastic Products Co., Ltd. (FEI: 3002803561) has 7 FDA import refusal record(s) in our database, spanning from 12/6/2004 to 6/20/2011.
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. Suzhou Linhua Plastic Products Co., Ltd.'s FEI number is 3002803561.
What types of violations has Suzhou Linhua Plastic Products Co., Ltd. received?
Suzhou Linhua Plastic Products Co., Ltd. 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 Suzhou Linhua Plastic Products Co., Ltd. come from?
All FDA import refusal data for Suzhou Linhua Plastic Products 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.