Kashmir Surgical Works
⚠️ High Risk
FEI: 3004765453 • Ambala, Haryana • INDIA
FEI Number
3004765453
Location
Ambala, Haryana
Country
INDIAAddress
1888 B/10 Chandigarh, BALDEV NAGAR, Ambala, Haryana, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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).
3904
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2025 | 86KYDSTRIP, SCHIRMER | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 8/12/2025 | 76EBALIGHT, SURGICAL HEADLIGHT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/12/2025 | 91DNCSTRIP, PAPER, SALICYLATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 86HJLLENS, CONDENSING, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/8/2025 | 86KYDSTRIP, SCHIRMER | Division of Southeast Imports (DSEI) | |
| 7/8/2025 | 86KYDSTRIP, SCHIRMER | Division of Southeast Imports (DSEI) | |
| 7/8/2025 | 86KYDSTRIP, SCHIRMER | Division of Southeast Imports (DSEI) | |
| 6/20/2025 | 63XCK12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | Division of Southeast Imports (DSEI) | |
| 6/12/2025 | 58QCY99OPHTHALMOLOGIC AGENT, NEC | Division of Southeast Imports (DSEI) | |
| 6/1/2025 | 63XCK12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | Division of Southeast Imports (DSEI) | |
| 3/11/2022 | 81GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER) | Division of Southeast Imports (DSEI) | |
| 12/29/2021 | 76NOFSYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) OF DENTAL RESTORATI | Division of Southeast Imports (DSEI) | |
| 10/4/2021 | 90KXKSOURCE, BRACHYTHERAPY, RADIONUCLIDE | Division of Southeast Imports (DSEI) | |
| 9/29/2021 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/29/2021 | 77ERAOTOSCOPE | Division of Southeast Imports (DSEI) | |
| 4/29/2021 | 86HOXCHART, VISUAL ACUITY | Division of Southeast Imports (DSEI) | |
| 3/27/2021 | 81GLGPLATELET COUNTING, MANUAL | Division of Southeast Imports (DSEI) | |
| 3/25/2021 | 81GHOHEMOCYTOMETER | Division of Southeast Imports (DSEI) | |
| 3/20/2021 | 86HLIOPHTHALMOSCOPE, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 2/1/2021 | 86HITTESTER, COLOR VISION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/12/2020 | 79MCYKIT, WOUND DRESSING | Division of Southeast Imports (DSEI) | |
| 12/4/2017 | 86HOXCHART, VISUAL ACUITY | Division of Southeast Imports (DSEI) | |
| 8/23/2017 | 81GHOHEMOCYTOMETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/1/2016 | 77ERAOTOSCOPE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/9/2015 | 86NQEMICROSCOPE, SPECULAR | New Orleans District Office (NOL-DO) | |
| 9/4/2015 | 77ERAOTOSCOPE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kashmir Surgical Works's FDA import refusal history?
Kashmir Surgical Works (FEI: 3004765453) has 28 FDA import refusal record(s) in our database, spanning from 9/4/2015 to 10/6/2025.
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. Kashmir Surgical Works's FEI number is 3004765453.
What types of violations has Kashmir Surgical Works received?
Kashmir Surgical Works has been cited for 7 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 Kashmir Surgical Works come from?
All FDA import refusal data for Kashmir Surgical Works 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.