Respironics Novametrix, LLC
⚠️ Moderate Risk
FEI: 1219324 • Wallingford, CT • UNITED STATES
FEI Number
1219324
Location
Wallingford, CT
Country
UNITED STATESAddress
5 Technology Dr, , Wallingford, CT, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 10/7/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | Division of Northeast Imports (DNEI) | |
| 9/17/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | Division of Northern Border Imports (DNBI) | |
| 9/22/2015 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/22/2015 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Respironics Novametrix, LLC's FDA import refusal history?
Respironics Novametrix, LLC (FEI: 1219324) has 4 FDA import refusal record(s) in our database, spanning from 9/22/2015 to 10/7/2020.
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. Respironics Novametrix, LLC's FEI number is 1219324.
What types of violations has Respironics Novametrix, LLC received?
Respironics Novametrix, LLC 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 Respironics Novametrix, LLC come from?
All FDA import refusal data for Respironics Novametrix, 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.