D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
⚠️ Moderate Risk
FEI: 3002806863 • Zuidland, Zuid-Holland • NETHERLANDS
FEI Number
3002806863
Location
Zuidland, Zuid-Holland
Country
NETHERLANDSAddress
Scheijdelveweg 2, , Zuidland, Zuid-Holland, Netherlands
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2015 | 86KYGDEVICE, IRRIGATION, OCULAR SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/22/2015 | 86HQFLASER, OPHTHALMIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2010 | 86HNRFORCEPS, OPHTHALMIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/13/2009 | 86HMXCANNULA, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 86HNFSCISSORS, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 86HNRFORCEPS, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 86HMXCANNULA, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 86HNFSCISSORS, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 86HNRFORCEPS, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 3/20/2008 | 86HQEINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 3/20/2008 | 86HMXCANNULA, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 3/20/2008 | 86MLZVITRECTOMY, INSTRUMENT CUTTER | Division of Southeast Imports (DSEI) | |
| 1/17/2007 | 86HKPINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/18/2004 | 85HISCONDOM | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 76EFNCOTTON, ROLL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2004 | 86HKOREFRACTOMETER, OPHTHALMIC | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is D.O.R.C. Dutch Opthalmic Research Center Intl B.V.'s FDA import refusal history?
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. (FEI: 3002806863) has 19 FDA import refusal record(s) in our database, spanning from 5/11/2004 to 7/22/2015.
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. D.O.R.C. Dutch Opthalmic Research Center Intl B.V.'s FEI number is 3002806863.
What types of violations has D.O.R.C. Dutch Opthalmic Research Center Intl B.V. received?
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. has been cited for 4 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 D.O.R.C. Dutch Opthalmic Research Center Intl B.V. come from?
All FDA import refusal data for D.O.R.C. Dutch Opthalmic Research Center Intl B.V. 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.