FIVE PAGODAS PHARMACY CO., LTD.
⚠️ Moderate Risk
FEI: 3010060326 • Thon Buri, Bangkok • THAILAND
FEI Number
3010060326
Location
Thon Buri, Bangkok
Country
THAILANDAddress
238, , Thon Buri, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 6/16/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 12/13/2013 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is FIVE PAGODAS PHARMACY CO., LTD.'s FDA import refusal history?
FIVE PAGODAS PHARMACY CO., LTD. (FEI: 3010060326) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2013 to 8/4/2016.
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. FIVE PAGODAS PHARMACY CO., LTD.'s FEI number is 3010060326.
What types of violations has FIVE PAGODAS PHARMACY CO., LTD. received?
FIVE PAGODAS PHARMACY 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 FIVE PAGODAS PHARMACY CO., LTD. come from?
All FDA import refusal data for FIVE PAGODAS PHARMACY 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.