Sri Johani Sdn Bhd
⚠️ Moderate Risk
FEI: 3002808247 • Selangor • MALAYSIA
FEI Number
3002808247
Location
Selangor
Country
MALAYSIAAddress
Lot Pt, 7178 Balakong N/V, Selangor, , Malaysia
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/6/2006 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/6/2006 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/7/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sri Johani Sdn Bhd's FDA import refusal history?
Sri Johani Sdn Bhd (FEI: 3002808247) has 4 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 8/2/2012.
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. Sri Johani Sdn Bhd's FEI number is 3002808247.
What types of violations has Sri Johani Sdn Bhd received?
Sri Johani Sdn Bhd 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 Sri Johani Sdn Bhd come from?
All FDA import refusal data for Sri Johani Sdn Bhd 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.