Kosol-Ampa Co., Ltd.
⚠️ Moderate Risk
FEI: 3004294561 • Muang Chon Buri, Chon Buri • THAILAND
FEI Number
3004294561
Location
Muang Chon Buri, Chon Buri
Country
THAILANDAddress
10/1, Moo 6; Napa T., Muang Chon Buri, 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
FSVP VIO
The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Kosol-Ampa Co., Ltd.'s FDA import refusal history?
Kosol-Ampa Co., Ltd. (FEI: 3004294561) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2005 to 3/23/2022.
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. Kosol-Ampa Co., Ltd.'s FEI number is 3004294561.
What types of violations has Kosol-Ampa Co., Ltd. received?
Kosol-Ampa Co., Ltd. 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 Kosol-Ampa Co., Ltd. come from?
All FDA import refusal data for Kosol-Ampa 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.