DIANTRA
⚠️ Moderate Risk
FEI: 3017109025 • Bekasi • INDONESIA
FEI Number
3017109025
Location
Bekasi
Country
INDONESIAAddress
Perum Alam Pesona Wanajaya, Blok P44; Cibitung No. 06, Bekasi, , 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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
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 |
|---|---|---|---|
| 4/20/2021 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | Division of Southeast Imports (DSEI) | |
| 4/20/2021 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | Division of Southeast Imports (DSEI) | |
| 9/28/2020 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DIANTRA's FDA import refusal history?
DIANTRA (FEI: 3017109025) has 3 FDA import refusal record(s) in our database, spanning from 9/28/2020 to 4/20/2021.
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. DIANTRA's FEI number is 3017109025.
What types of violations has DIANTRA received?
DIANTRA 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 DIANTRA come from?
All FDA import refusal data for DIANTRA 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.