Pt Oneject Indonesia
⚠️ Moderate Risk
FEI: 3005806438 • Kab Bekasi, Jawa Barat • INDONESIA
FEI Number
3005806438
Location
Kab Bekasi, Jawa Barat
Country
INDONESIAAddress
Jalan Anggrek VII No.41, Kawasan Industri, Terpadu Indonesia China (KITIC), Kab Bekasi, Jawa 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Pt Oneject Indonesia's FDA import refusal history?
Pt Oneject Indonesia (FEI: 3005806438) has 1 FDA import refusal record(s) in our database, spanning from 2/7/2022 to 2/7/2022.
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 Oneject Indonesia's FEI number is 3005806438.
What types of violations has Pt Oneject Indonesia received?
Pt Oneject Indonesia has been cited for 1 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 Oneject Indonesia come from?
All FDA import refusal data for Pt Oneject Indonesia 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.