CLOUDCOMMERCE.CO
⚠️ Moderate Risk
FEI: 3014475469 • Bangkok • THAILAND
FEI Number
3014475469
Location
Bangkok
Country
THAILANDAddress
1 269 Chaengwattana 14, , Bangkok, , Thailand
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
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).
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).
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 |
|---|---|---|---|
| 1/19/2023 | 75OTVRESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES | Division of Southeast Imports (DSEI) | |
| 1/19/2023 | 75OTVRESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES | Division of Southeast Imports (DSEI) | |
| 7/31/2020 | 65QAY02BOTOX | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2020 | 61XBY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CLOUDCOMMERCE.CO's FDA import refusal history?
CLOUDCOMMERCE.CO (FEI: 3014475469) has 5 FDA import refusal record(s) in our database, spanning from 10/31/2019 to 1/19/2023.
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. CLOUDCOMMERCE.CO's FEI number is 3014475469.
What types of violations has CLOUDCOMMERCE.CO received?
CLOUDCOMMERCE.CO 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 CLOUDCOMMERCE.CO come from?
All FDA import refusal data for CLOUDCOMMERCE.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.