PF Soins de Sante SRI
⚠️ High Risk
FEI: 3002806439 • Saint-Laurent, Quebec • CANADA
FEI Number
3002806439
Location
Saint-Laurent, Quebec
Country
CANADAAddress
1025 Marcel-Laurin Blvd, , 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2025 | 62LOY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2017 | 65JCA21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2011 | 66MDB86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 61NCE80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/15/2008 | 66MIY99TRANQUILIZER N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 66MIY99TRANQUILIZER N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 66MIS99TRANQUILIZER N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 63AIA99BONE CALCIUM REGULATOR N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 63AIS99BONE CALCIUM REGULATOR N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 62IIY99ANTI-NEOPLASTIC N.E.C. | New England District Office (NWE-DO) | |
| 8/15/2008 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | New England District Office (NWE-DO) | |
| 5/5/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/5/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/5/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/5/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/5/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/26/2008 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/26/2008 | 60CIE02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/26/2008 | 60CIE02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/26/2008 | 60CIE02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 54BBY07IRON (MINERAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/26/2007 | 61NCB80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 1/3/2007 | 64GDA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2006 | 62CCP99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/26/2006 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/17/2005 | 66MAY86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 64GDB99ESTROGEN N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/13/2004 | 64GCB16CONJUGATED ESTROGENS (ESTROGEN) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/1/2002 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/1/2002 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 11/20/2001 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/20/2001 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/9/2001 | 64UDA99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PF Soins de Sante SRI's FDA import refusal history?
PF Soins de Sante SRI (FEI: 3002806439) has 62 FDA import refusal record(s) in our database, spanning from 10/9/2001 to 2/6/2025.
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. PF Soins de Sante SRI's FEI number is 3002806439.
What types of violations has PF Soins de Sante SRI received?
PF Soins de Sante SRI has been cited for 5 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 PF Soins de Sante SRI come from?
All FDA import refusal data for PF Soins de Sante SRI 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.