B.V. KATWIJK CHEMIE
⚠️ Moderate Risk
FEI: 1000173675 • Katwijk Zh, Zuid-Holland • NETHERLANDS
FEI Number
1000173675
Location
Katwijk Zh, Zuid-Holland
Country
NETHERLANDSAddress
Snijderstraat 6, , Katwijk Zh, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2016 | 61HAS45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/27/2008 | 61GCS45SULFACETAMIDE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/5/2008 | 61GCS45SULFACETAMIDE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is B.V. KATWIJK CHEMIE's FDA import refusal history?
B.V. KATWIJK CHEMIE (FEI: 1000173675) has 3 FDA import refusal record(s) in our database, spanning from 8/5/2008 to 10/18/2016.
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. B.V. KATWIJK CHEMIE's FEI number is 1000173675.
What types of violations has B.V. KATWIJK CHEMIE received?
B.V. KATWIJK CHEMIE 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 B.V. KATWIJK CHEMIE come from?
All FDA import refusal data for B.V. KATWIJK CHEMIE 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.