Uthai Ropawee
⚠️ Moderate Risk
FEI: 3005199045 • Nong Yai, Chon Buri • THAILAND
FEI Number
3005199045
Location
Nong Yai, Chon Buri
Country
THAILANDAddress
Moo 6, 69 Tambon Ponghai, Nong Yai, Chon Buri, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/15/2005 | 54FEJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/15/2005 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/15/2005 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Uthai Ropawee's FDA import refusal history?
Uthai Ropawee (FEI: 3005199045) has 4 FDA import refusal record(s) in our database, spanning from 11/15/2005 to 3/7/2006.
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. Uthai Ropawee's FEI number is 3005199045.
What types of violations has Uthai Ropawee received?
Uthai Ropawee has been cited for 2 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 Uthai Ropawee come from?
All FDA import refusal data for Uthai Ropawee 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.