Lernapharm (Loris) Inc.
⚠️ High Risk
FEI: 3004158845 • Saint-Laurent, Quebec • CANADA
FEI Number
3004158845
Location
Saint-Laurent, Quebec
Country
CANADAAddress
2323 Halpern St, , Saint-Laurent, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2021 | 62FAY99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2021 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/22/2021 | 62FBY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/19/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/3/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/3/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/3/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/3/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/3/2020 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/16/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/16/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/16/2019 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/3/2019 | 62FAY34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/25/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/25/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/25/2018 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/14/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/29/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/29/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/29/2018 | 62FAK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/30/2015 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lernapharm (Loris) Inc.'s FDA import refusal history?
Lernapharm (Loris) Inc. (FEI: 3004158845) has 34 FDA import refusal record(s) in our database, spanning from 10/30/2015 to 10/4/2021.
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. Lernapharm (Loris) Inc.'s FEI number is 3004158845.
What types of violations has Lernapharm (Loris) Inc. received?
Lernapharm (Loris) Inc. 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 Lernapharm (Loris) Inc. come from?
All FDA import refusal data for Lernapharm (Loris) 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.