PT.ADI DHARMA BOTANICAL
⚠️ Moderate Risk
FEI: 3012929440 • INDONESIA • INDONESIA
FEI Number
3012929440
Location
INDONESIA
Country
INDONESIAAddress
JL.PURNAMA PRINTIS 1 NO, , INDONESIA, , Indonesia
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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2019 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2016 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Seattle District Office (SEA-DO) |
| 12/22/2016 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Seattle District Office (SEA-DO) |
| 12/22/2016 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PT.ADI DHARMA BOTANICAL's FDA import refusal history?
PT.ADI DHARMA BOTANICAL (FEI: 3012929440) has 4 FDA import refusal record(s) in our database, spanning from 12/22/2016 to 4/25/2019.
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. PT.ADI DHARMA BOTANICAL's FEI number is 3012929440.
What types of violations has PT.ADI DHARMA BOTANICAL received?
PT.ADI DHARMA BOTANICAL 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 PT.ADI DHARMA BOTANICAL come from?
All FDA import refusal data for PT.ADI DHARMA BOTANICAL 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.