Golden Elephant Dispensary
⚠️ Moderate Risk
FEI: 1000411606 • Bangkok • THAILAND
FEI Number
1000411606
Location
Bangkok
Country
THAILANDAddress
1099/9 Moo 12 Bang Na, , 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 1/29/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/29/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/11/2013 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Los Angeles District Office (LOS-DO) | |
| 3/11/2013 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/10/2013 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/28/2012 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Los Angeles District Office (LOS-DO) | |
| 11/28/2012 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/30/2012 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Los Angeles District Office (LOS-DO) | |
| 5/23/2012 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/23/2012 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/25/2011 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Los Angeles District Office (LOS-DO) | |
| 11/20/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/11/2008 | 62MPJ01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Golden Elephant Dispensary's FDA import refusal history?
Golden Elephant Dispensary (FEI: 1000411606) has 20 FDA import refusal record(s) in our database, spanning from 6/11/2008 to 1/29/2014.
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. Golden Elephant Dispensary's FEI number is 1000411606.
What types of violations has Golden Elephant Dispensary received?
Golden Elephant Dispensary has been cited for 6 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 Golden Elephant Dispensary come from?
All FDA import refusal data for Golden Elephant Dispensary 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.