PT Wrp Buana Multicorp
⚠️ Moderate Risk
FEI: 3003921460 • Medan • INDONESIA
FEI Number
3003921460
Location
Medan
Country
INDONESIAAddress
Jl. Jermal No 20-B Kelurahan, , Medan, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 11/5/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Florida District Office (FLA-DO) |
| 10/27/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Florida District Office (FLA-DO) |
| 10/16/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 10/16/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/16/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/26/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/26/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/30/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/23/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/23/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 5/8/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 5/8/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is PT Wrp Buana Multicorp's FDA import refusal history?
PT Wrp Buana Multicorp (FEI: 3003921460) has 12 FDA import refusal record(s) in our database, spanning from 5/8/2009 to 11/5/2009.
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 Wrp Buana Multicorp's FEI number is 3003921460.
What types of violations has PT Wrp Buana Multicorp received?
PT Wrp Buana Multicorp 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 Wrp Buana Multicorp come from?
All FDA import refusal data for PT Wrp Buana Multicorp 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.