PT. BONADIA EKA SEJAHTERA
⚠️ Moderate Risk
FEI: 3032292640 • Kab. Bogor, Jawa barat • INDONESIA
FEI Number
3032292640
Location
Kab. Bogor, Jawa barat
Country
INDONESIAAddress
Perum Gardenia Ruko Gardenia Blok B No. 7 Rt. 006 Rw. 021, Cikeas Udik, Gunung Putri, , Kab. Bogor, 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
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is PT. BONADIA EKA SEJAHTERA's FDA import refusal history?
PT. BONADIA EKA SEJAHTERA (FEI: 3032292640) has 1 FDA import refusal record(s) in our database, spanning from 12/6/2024 to 12/6/2024.
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. BONADIA EKA SEJAHTERA's FEI number is 3032292640.
What types of violations has PT. BONADIA EKA SEJAHTERA received?
PT. BONADIA EKA SEJAHTERA 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. BONADIA EKA SEJAHTERA come from?
All FDA import refusal data for PT. BONADIA EKA SEJAHTERA 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.