Collagen Matrix Inc
⚠️ Moderate Risk
FEI: 3008817245 • Oakland, NJ • UNITED STATES
FEI Number
3008817245
Location
Oakland, NJ
Country
UNITED STATESAddress
15 Thornton Rd, , Oakland, NJ, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2016 | 76NPLBARRIER, ANIMAL SOURCE, DENTAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/17/2014 | 76NPLBARRIER, ANIMAL SOURCE, DENTAL | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 11/8/2013 | 76PEMDENTAL BARRIERS AND SLEEVES | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 76PEMDENTAL BARRIERS AND SLEEVES | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 76PEMDENTAL BARRIERS AND SLEEVES | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Collagen Matrix Inc's FDA import refusal history?
Collagen Matrix Inc (FEI: 3008817245) has 5 FDA import refusal record(s) in our database, spanning from 11/8/2013 to 4/22/2016.
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. Collagen Matrix Inc's FEI number is 3008817245.
What types of violations has Collagen Matrix Inc received?
Collagen Matrix Inc has been cited for 3 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 Collagen Matrix Inc come from?
All FDA import refusal data for Collagen Matrix Inc 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.