Ausa Co.,Ltd.
⚠️ Moderate Risk
FEI: 3009104432 • Nonthaburi • THAILAND
FEI Number
3009104432
Location
Nonthaburi
Country
THAILANDAddress
55, 40 Tumbon Lampo,Bangbuetong, Nonthaburi, , 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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 |
|---|---|---|---|
| 7/21/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southeast Imports (DSEI) | |
| 7/21/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southeast Imports (DSEI) | |
| 7/21/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southeast Imports (DSEI) | |
| 5/26/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Ausa Co.,Ltd.'s FDA import refusal history?
Ausa Co.,Ltd. (FEI: 3009104432) has 4 FDA import refusal record(s) in our database, spanning from 5/26/2017 to 7/21/2017.
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. Ausa Co.,Ltd.'s FEI number is 3009104432.
What types of violations has Ausa Co.,Ltd. received?
Ausa 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 Ausa Co.,Ltd. come from?
All FDA import refusal data for Ausa 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.