Laboratoire Provence Canada, Inc.
⚠️ Moderate Risk
FEI: 3007264880 • Drummondville, Quebec • CANADA
FEI Number
3007264880
Location
Drummondville, Quebec
Country
CANADAAddress
675 Bergeron St, , Drummondville, Quebec, 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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2020 | 61HBJ99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/3/2020 | 61HBJ99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/3/2020 | 61HBJ99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Laboratoire Provence Canada, Inc.'s FDA import refusal history?
Laboratoire Provence Canada, Inc. (FEI: 3007264880) has 3 FDA import refusal record(s) in our database, spanning from 4/3/2020 to 4/3/2020.
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. Laboratoire Provence Canada, Inc.'s FEI number is 3007264880.
What types of violations has Laboratoire Provence Canada, Inc. received?
Laboratoire Provence Canada, Inc. has been cited for 2 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 Laboratoire Provence Canada, Inc. come from?
All FDA import refusal data for Laboratoire Provence Canada, 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.