Pt Indah Multi Kreasi
⚠️ Moderate Risk
FEI: 3004463861 • Semarang • INDONESIA
FEI Number
3004463861
Location
Semarang
Country
INDONESIAAddress
Dalam Ix 1, , Semarang, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2004 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/8/2004 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/8/2004 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/8/2004 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pt Indah Multi Kreasi's FDA import refusal history?
Pt Indah Multi Kreasi (FEI: 3004463861) has 4 FDA import refusal record(s) in our database, spanning from 10/8/2004 to 10/8/2004.
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. Pt Indah Multi Kreasi's FEI number is 3004463861.
What types of violations has Pt Indah Multi Kreasi received?
Pt Indah Multi Kreasi 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 Pt Indah Multi Kreasi come from?
All FDA import refusal data for Pt Indah Multi Kreasi 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.