CTT Co., Ltd
⚠️ Moderate Risk
FEI: 3016717085 • Huizhou, Guangdong • CHINA
FEI Number
3016717085
Location
Huizhou, Guangdong
Country
CHINAAddress
Building 2 Of Industril Park No 197 Xinhua Blvd, Tongqiao Town,Zhongkai High-Tech Zone, , Huizhou, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2021 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 8/12/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 8/7/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 6/26/2020 | 80OUKSURGICAL MASK WITH ANTIMICROBIAL/ANTIVIRAL AGENT | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 6/15/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CTT Co., Ltd's FDA import refusal history?
CTT Co., Ltd (FEI: 3016717085) has 8 FDA import refusal record(s) in our database, spanning from 6/15/2020 to 1/25/2021.
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. CTT Co., Ltd's FEI number is 3016717085.
What types of violations has CTT Co., Ltd received?
CTT Co., Ltd 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 CTT Co., Ltd come from?
All FDA import refusal data for CTT 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.