LOWE OPCO INC.
⚠️ Moderate Risk
FEI: 3017084668 • Edmonton, Alberta • CANADA
FEI Number
3017084668
Location
Edmonton, Alberta
Country
CANADAAddress
15018 116 Ave Nw, , Edmonton, Alberta, 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).
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 |
|---|---|---|---|
| 8/8/2023 | 61FAL51CHLOROAZODIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Northern Border Imports (DNBI) | |
| 8/13/2020 | 61XAA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 8/4/2020 | 61TCF08DIPHENIDOL HCL (ANTI-EMETIC/NAUSEANT) | Division of Northern Border Imports (DNBI) | |
| 8/4/2020 | 60LBR01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 8/4/2020 | 60LBR01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 8/4/2020 | 60LBR01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 8/4/2020 | 61XDC18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | Division of West Coast Imports (DWCI) | |
| 8/4/2020 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2020 | 85HHDPAD, MENSTRUAL, UNSCENTED | Division of West Coast Imports (DWCI) | |
| 8/4/2020 | 61XCY99ANTI-HISTAMINIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/4/2020 | 65FDL06WATER, PURIFIED (EYEWASH) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is LOWE OPCO INC.'s FDA import refusal history?
LOWE OPCO INC. (FEI: 3017084668) has 11 FDA import refusal record(s) in our database, spanning from 8/4/2020 to 8/8/2023.
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. LOWE OPCO INC.'s FEI number is 3017084668.
What types of violations has LOWE OPCO INC. received?
LOWE OPCO 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 LOWE OPCO INC. come from?
All FDA import refusal data for LOWE OPCO 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.