Safetec
⚠️ Moderate Risk
FEI: 3004940906 • Buffalo, NY • UNITED STATES
FEI Number
3004940906
Location
Buffalo, NY
Country
UNITED STATESAddress
1055 E Delavan Ave # NY, , Buffalo, NY, United States
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 |
|---|---|---|---|
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Safetec's FDA import refusal history?
Safetec (FEI: 3004940906) has 7 FDA import refusal record(s) in our database, spanning from 3/12/2009 to 3/12/2009.
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. Safetec's FEI number is 3004940906.
What types of violations has Safetec received?
Safetec 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 Safetec come from?
All FDA import refusal data for Safetec 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.