Pillar5 Pharma Inc.
⚠️ Moderate Risk
FEI: 3000241849 • Arnprior, Ontario • CANADA
FEI Number
3000241849
Location
Arnprior, Ontario
Country
CANADAAddress
365 Madawaska Blvd, , Arnprior, Ontario, 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
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).
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).
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.
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 |
|---|---|---|---|
| 3/8/2021 | 60CBK09PHENYLEPHRINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 1/10/2006 | 65VAB99SEDATIVE N.E.C. | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 11/1/2004 | 62GCP99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/1/2004 | 56YCP99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/9/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pillar5 Pharma Inc.'s FDA import refusal history?
Pillar5 Pharma Inc. (FEI: 3000241849) has 5 FDA import refusal record(s) in our database, spanning from 10/9/2001 to 3/8/2021.
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. Pillar5 Pharma Inc.'s FEI number is 3000241849.
What types of violations has Pillar5 Pharma Inc. received?
Pillar5 Pharma 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 Pillar5 Pharma Inc. come from?
All FDA import refusal data for Pillar5 Pharma 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.