Sea-Air Export Co Ltd
⚠️ Moderate Risk
FEI: 3003241968 • Pathum Wan, Bangkok • THAILAND
FEI Number
3003241968
Location
Pathum Wan, Bangkok
Country
THAILANDAddress
Tac House 5/F1 Soi Ruam Rudi, Ploenchit, , Pathum Wan, 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
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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 |
|---|---|---|---|
| 11/18/2004 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 8/15/2003 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 8/15/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 8/15/2003 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2002 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/12/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/3/2001 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sea-Air Export Co Ltd's FDA import refusal history?
Sea-Air Export Co Ltd (FEI: 3003241968) has 12 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 11/18/2004.
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. Sea-Air Export Co Ltd's FEI number is 3003241968.
What types of violations has Sea-Air Export Co Ltd received?
Sea-Air Export Co Ltd has been cited for 4 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 Sea-Air Export Co Ltd come from?
All FDA import refusal data for Sea-Air Export 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.