SOMCHIT DISPENSARY CO., LTD
⚠️ Moderate Risk
FEI: 3017020267 • Chatuchak, Bangkok • THAILAND
FEI Number
3017020267
Location
Chatuchak, Bangkok
Country
THAILANDAddress
23 Lat Phrao Rd, , Chatuchak, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
TPNOWRNLBL
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2021 | 98CAA99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 3781TPNOWRNLBL | Division of Southeast Imports (DSEI) |
| 12/31/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 12/31/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 12/31/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SOMCHIT DISPENSARY CO., LTD's FDA import refusal history?
SOMCHIT DISPENSARY CO., LTD (FEI: 3017020267) has 4 FDA import refusal record(s) in our database, spanning from 12/31/2020 to 1/19/2021.
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. SOMCHIT DISPENSARY CO., LTD's FEI number is 3017020267.
What types of violations has SOMCHIT DISPENSARY CO., LTD received?
SOMCHIT DISPENSARY 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 SOMCHIT DISPENSARY CO., LTD come from?
All FDA import refusal data for SOMCHIT DISPENSARY 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.