Monkey Holding Peach Brand Company Ltd.
⚠️ Moderate Risk
FEI: 3004116897 • Bang Na, Bangkok • THAILAND
FEI Number
3004116897
Location
Bang Na, Bangkok
Country
THAILANDAddress
4 Soi Bangna-Trad-15, , 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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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) | |
| 2/16/2012 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 1/25/2012 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/30/2009 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/14/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Monkey Holding Peach Brand Company Ltd.'s FDA import refusal history?
Monkey Holding Peach Brand Company Ltd. (FEI: 3004116897) has 6 FDA import refusal record(s) in our database, spanning from 5/14/2005 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. Monkey Holding Peach Brand Company Ltd.'s FEI number is 3004116897.
What types of violations has Monkey Holding Peach Brand Company Ltd. received?
Monkey Holding Peach Brand Company Ltd. has been cited for 4 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 Monkey Holding Peach Brand Company Ltd. come from?
All FDA import refusal data for Monkey Holding Peach Brand Company 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.