Pine Valley Pharmacy
⚠️ High Risk
FEI: 3004124387 • Woodbridge, ON • CANADA
FEI Number
3004124387
Location
Woodbridge, ON
Country
CANADAAddress
7700 Pine Valley Dr Unit 6 On, , Woodbridge, ON, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2003 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 60RDC19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 60SDC27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 65VCC57ZALEPLON (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pine Valley Pharmacy's FDA import refusal history?
Pine Valley Pharmacy (FEI: 3004124387) has 7 FDA import refusal record(s) in our database, spanning from 10/2/2003 to 10/2/2003.
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. Pine Valley Pharmacy's FEI number is 3004124387.
What types of violations has Pine Valley Pharmacy received?
Pine Valley Pharmacy has been cited for 1 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 Pine Valley Pharmacy come from?
All FDA import refusal data for Pine Valley Pharmacy 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.