OLIC (Thailand) Limited
⚠️ High Risk
FEI: 3004039360 • Bang Pa-In, Ayutthaya • THAILAND
FEI Number
3004039360
Location
Bang Pa-In, Ayutthaya
Country
THAILANDAddress
Bangpa-In Industrial Estate, 166 Moo 16, Udomsorayuth Rd., Bang Pa-In, Ayutthaya, Thailand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2024 | 60SBL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/24/2020 | 54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/16/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/13/2015 | 61WAL47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Cincinnati District Office (CIN-DO) | |
| 2/13/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/8/2007 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/8/2007 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is OLIC (Thailand) Limited's FDA import refusal history?
OLIC (Thailand) Limited (FEI: 3004039360) has 8 FDA import refusal record(s) in our database, spanning from 8/8/2007 to 8/16/2024.
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. OLIC (Thailand) Limited's FEI number is 3004039360.
What types of violations has OLIC (Thailand) Limited received?
OLIC (Thailand) Limited 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 OLIC (Thailand) Limited come from?
All FDA import refusal data for OLIC (Thailand) Limited 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.