Global Trans Maju empatempat
⚠️ Moderate Risk
FEI: 3013253916 • Jakarta, Jakarta Raya • INDONESIA
FEI Number
3013253916
Location
Jakarta, Jakarta Raya
Country
INDONESIAAddress
Jl. Raya Rawa Renggas Kp. Tukang Kajang, , Jakarta, Jakarta Raya, 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
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.
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.
ANDRO
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2017 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 12/20/2017 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 9/12/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 4/26/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Global Trans Maju empatempat's FDA import refusal history?
Global Trans Maju empatempat (FEI: 3013253916) has 4 FDA import refusal record(s) in our database, spanning from 4/26/2016 to 12/20/2017.
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. Global Trans Maju empatempat's FEI number is 3013253916.
What types of violations has Global Trans Maju empatempat received?
Global Trans Maju empatempat has been cited for 3 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 Global Trans Maju empatempat come from?
All FDA import refusal data for Global Trans Maju empatempat 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.