Hermawan Rezadinata
⚠️ Moderate Risk
FEI: 3012057664 • Pontianakpontianak • INDONESIA
FEI Number
3012057664
Location
Pontianakpontianak
Country
INDONESIAAddress
Jl. Karya Komp Kurnia Karya No 15shipper, , Pontianakpontianak, , 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.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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 |
|---|---|---|---|
| 6/28/2016 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Cincinnati District Office (CIN-DO) | |
| 6/7/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 4/5/2016 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hermawan Rezadinata's FDA import refusal history?
Hermawan Rezadinata (FEI: 3012057664) has 3 FDA import refusal record(s) in our database, spanning from 4/5/2016 to 6/28/2016.
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. Hermawan Rezadinata's FEI number is 3012057664.
What types of violations has Hermawan Rezadinata received?
Hermawan Rezadinata 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 Hermawan Rezadinata come from?
All FDA import refusal data for Hermawan Rezadinata 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.