CV. VISI INDO PRIMA
⚠️ Moderate Risk
FEI: 3014523682 • Yogyakarta • INDONESIA
FEI Number
3014523682
Location
Yogyakarta
Country
INDONESIAAddress
Perum Alam Sotya Blok B5 Pacar Brajan, Rt 008; Wonokromo Pleret Bantul, Yogyakarta, , 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.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
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.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
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 |
|---|---|---|---|
| 9/19/2019 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 5/15/2019 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of West Coast Imports (DWCI) | |
| 5/15/2019 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is CV. VISI INDO PRIMA's FDA import refusal history?
CV. VISI INDO PRIMA (FEI: 3014523682) has 3 FDA import refusal record(s) in our database, spanning from 5/15/2019 to 9/19/2019.
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. CV. VISI INDO PRIMA's FEI number is 3014523682.
What types of violations has CV. VISI INDO PRIMA received?
CV. VISI INDO PRIMA 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 CV. VISI INDO PRIMA come from?
All FDA import refusal data for CV. VISI INDO PRIMA 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.