Lab Testing Group
⚠️ Moderate Risk
FEI: 3012300232 • Scarborough, Ontario • CANADA
FEI Number
3012300232
Location
Scarborough, Ontario
Country
CANADAAddress
1232 Kingston Rd, , Scarborough, Ontario, 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 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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/29/2019 | 62CAD04CLONIDINE TRANSDERMAL PATCHES | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 83LIODEVICE, SPECIMEN COLLECTION | Detroit District Office (DET-DO) | |
| 2/28/2017 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | New Orleans District Office (NOL-DO) | |
| 2/27/2017 | 75PJEBLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING | Division of Southeast Imports (DSEI) | |
| 2/21/2017 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | New Orleans District Office (NOL-DO) | |
| 2/13/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Detroit District Office (DET-DO) | |
| 1/24/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Division of Southeast Imports (DSEI) | |
| 1/24/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Detroit District Office (DET-DO) | |
| 1/11/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | New Orleans District Office (NOL-DO) | |
| 1/11/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | New Orleans District Office (NOL-DO) | |
| 1/11/2017 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Division of Southeast Imports (DSEI) | |
| 12/9/2016 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Division of Southeast Imports (DSEI) | |
| 12/9/2016 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lab Testing Group's FDA import refusal history?
Lab Testing Group (FEI: 3012300232) has 13 FDA import refusal record(s) in our database, spanning from 12/9/2016 to 1/29/2019.
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. Lab Testing Group's FEI number is 3012300232.
What types of violations has Lab Testing Group received?
Lab Testing Group has been cited for 4 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 Lab Testing Group come from?
All FDA import refusal data for Lab Testing Group 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.