Adi Dharma Putra
⚠️ Moderate Risk
FEI: 3011772014 • Putussibau, Kalimantan Barat • INDONESIA
FEI Number
3011772014
Location
Putussibau, Kalimantan Barat
Country
INDONESIAAddress
Jongkong Kabupaten Kapuas Hulu, , Putussibau, Kalimantan Barat, 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).
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2020 | 54KIT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of West Coast Imports (DWCI) | |
| 3/22/2018 | 54JFR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | Division of Northeast Imports (DNEI) | |
| 3/31/2017 | 54KBY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 54JYR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 1/4/2017 | 50CAH99RAW MATERIALS FOR COLOR MANUFACTURING, N.E.C. | 2120UNSFDIETSP | Division of West Coast Imports (DWCI) |
| 12/27/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Seattle District Office (SEA-DO) |
| 3/9/2016 | 54FYT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Adi Dharma Putra's FDA import refusal history?
Adi Dharma Putra (FEI: 3011772014) has 7 FDA import refusal record(s) in our database, spanning from 3/9/2016 to 6/3/2020.
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. Adi Dharma Putra's FEI number is 3011772014.
What types of violations has Adi Dharma Putra received?
Adi Dharma Putra 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 Adi Dharma Putra come from?
All FDA import refusal data for Adi Dharma Putra 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.