Devakam Apothecary Hall Co Ltd
⚠️ Moderate Risk
FEI: 1000443050 • Samutprakarn • THAILAND
FEI Number
1000443050
Location
Samutprakarn
Country
THAILANDAddress
12/571 M 15 Bangna Thad, , Samutprakarn, , 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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 11/18/2015 | 60L99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/7/2011 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 9/7/2011 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/19/2009 | 60LBJ99ANALGESIC, N.E.C. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Devakam Apothecary Hall Co Ltd's FDA import refusal history?
Devakam Apothecary Hall Co Ltd (FEI: 1000443050) has 7 FDA import refusal record(s) in our database, spanning from 6/19/2009 to 5/26/2017.
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. Devakam Apothecary Hall Co Ltd's FEI number is 1000443050.
What types of violations has Devakam Apothecary Hall Co Ltd received?
Devakam Apothecary Hall Co Ltd 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 Devakam Apothecary Hall Co Ltd come from?
All FDA import refusal data for Devakam Apothecary Hall 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.