Csli Co Ltd
⚠️ Moderate Risk
FEI: 3003896924 • Shanghai, Shanghai • CHINA
FEI Number
3003896924
Location
Shanghai, Shanghai
Country
CHINAAddress
665 Dong Chang Zhi Road, , Shanghai, Shanghai, 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
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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.
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).
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/14/2012 | 65PCB03TAMSULOSIN HCL (REGULATOR) | New Orleans District Office (NOL-DO) | |
| 11/15/2004 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | New England District Office (NWE-DO) | |
| 7/14/2004 | 64ADL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 7/14/2004 | 64ADL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 7/14/2004 | 64ADL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 7/14/2004 | 64ADL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Csli Co Ltd's FDA import refusal history?
Csli Co Ltd (FEI: 3003896924) has 6 FDA import refusal record(s) in our database, spanning from 7/14/2004 to 2/14/2012.
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. Csli Co Ltd's FEI number is 3003896924.
What types of violations has Csli Co Ltd received?
Csli Co Ltd 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 Csli Co Ltd come from?
All FDA import refusal data for Csli 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.