Narang Medical Ltd.
⚠️ Moderate Risk
FEI: 3004574120 • New Delhi, Delhi • INDIA
FEI Number
3004574120
Location
New Delhi, Delhi
Country
INDIAAddress
46 Narang Tower, Community Centre, New Delhi, Delhi, India
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87NDFPLATE, FIXATION, BONE, NON-SPINAL, METALLIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 87KXDPROSTHESIS, HIP, CONSTRAINED, METAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Narang Medical Ltd.'s FDA import refusal history?
Narang Medical Ltd. (FEI: 3004574120) has 38 FDA import refusal record(s) in our database, spanning from 3/18/2010 to 3/18/2010.
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. Narang Medical Ltd.'s FEI number is 3004574120.
What types of violations has Narang Medical Ltd. received?
Narang Medical Ltd. 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 Narang Medical Ltd. come from?
All FDA import refusal data for Narang Medical Ltd. 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.