HOSPICE HEALTHCARE CORPORATION
⚠️ Moderate Risk
FEI: 3014766164 • Kirkland, QC • CANADA
FEI Number
3014766164
Location
Kirkland, QC
Country
CANADAAddress
17 300 Trans-Canada Highway, , Kirkland, QC, 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 |
|---|---|---|---|
| 12/3/2018 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/3/2018 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/3/2018 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HOSPICE HEALTHCARE CORPORATION's FDA import refusal history?
HOSPICE HEALTHCARE CORPORATION (FEI: 3014766164) has 3 FDA import refusal record(s) in our database, spanning from 12/3/2018 to 12/3/2018.
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. HOSPICE HEALTHCARE CORPORATION's FEI number is 3014766164.
What types of violations has HOSPICE HEALTHCARE CORPORATION received?
HOSPICE HEALTHCARE CORPORATION 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 HOSPICE HEALTHCARE CORPORATION come from?
All FDA import refusal data for HOSPICE HEALTHCARE CORPORATION 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.