Bristhish Dispensary Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004008405 • Smut Prakarn • THAILAND
FEI Number
3004008405
Location
Smut Prakarn
Country
THAILANDAddress
272 Teparuk Road, , Smut Prakarn, , 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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2014 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/3/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Los Angeles District Office (LOS-DO) | |
| 1/18/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 12/1/2009 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bristhish Dispensary Co.,Ltd.'s FDA import refusal history?
Bristhish Dispensary Co.,Ltd. (FEI: 3004008405) has 4 FDA import refusal record(s) in our database, spanning from 12/1/2009 to 9/4/2014.
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. Bristhish Dispensary Co.,Ltd.'s FEI number is 3004008405.
What types of violations has Bristhish Dispensary Co.,Ltd. received?
Bristhish Dispensary Co.,Ltd. has been cited for 5 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 Bristhish Dispensary Co.,Ltd. come from?
All FDA import refusal data for Bristhish Dispensary 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.