Burpee Materials Technology, LLC
✅ Low Risk
FEI: 3005089785 • Eatontown, NJ • UNITED STATES
FEI Number
3005089785
Location
Eatontown, NJ
Country
UNITED STATESAddress
15 Christopher Way, , Eatontown, NJ, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2019 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Burpee Materials Technology, LLC's FDA import refusal history?
Burpee Materials Technology, LLC (FEI: 3005089785) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2019 to 6/3/2019.
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. Burpee Materials Technology, LLC's FEI number is 3005089785.
What types of violations has Burpee Materials Technology, LLC received?
Burpee Materials Technology, LLC has been cited for 2 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 Burpee Materials Technology, LLC come from?
All FDA import refusal data for Burpee Materials Technology, LLC 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.