Anogen
⚠️ Moderate Risk
FEI: 3009090898 • Mississauga, ON • CANADA
FEI Number
3009090898
Location
Mississauga, ON
Country
CANADAAddress
2335 Derry Rd East Unit 23, , Mississauga, ON, Canada
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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 |
|---|---|---|---|
| 6/20/2012 | 83LQIHEPATITIS DELTA SEROLOGICAL REAGENTS | 118NOT LISTED | Detroit District Office (DET-DO) |
| 9/29/2011 | 75JJYMULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) | New Orleans District Office (NOL-DO) | |
| 9/29/2011 | 75JJYMULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) | New Orleans District Office (NOL-DO) | |
| 7/10/2006 | 81MANASSAY, INTERLEUKIN | New York District Office (NYK-DO) | |
| 2/25/2004 | 81MTPANTIBODY TO HTLV-1, ELISA | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Anogen's FDA import refusal history?
Anogen (FEI: 3009090898) has 5 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 6/20/2012.
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. Anogen's FEI number is 3009090898.
What types of violations has Anogen received?
Anogen has been cited for 5 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 Anogen come from?
All FDA import refusal data for Anogen 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.