Kedarling Surgical
⚠️ Moderate Risk
FEI: 3006717284 • Bombay • INDIA
FEI Number
3006717284
Location
Bombay
Country
INDIAAddress
KRISHNA SAWANT CHAWL,,, VAISAITPADA-2, KURAD VILLAGE, Bombay, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2008 | 86HNASPUD, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HOBCLAMP, MUSCLE, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HLNGAUGE, LENS, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HNHRING, OPHTHALMIC (FLIERINGA) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HQLLENS, INTRAOCULAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HNNKNIFE, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 86HNXDEPRESSOR, ORBITAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kedarling Surgical's FDA import refusal history?
Kedarling Surgical (FEI: 3006717284) has 8 FDA import refusal record(s) in our database, spanning from 3/6/2008 to 3/6/2008.
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. Kedarling Surgical's FEI number is 3006717284.
What types of violations has Kedarling Surgical received?
Kedarling Surgical 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 Kedarling Surgical come from?
All FDA import refusal data for Kedarling Surgical 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.