Piramal Healthcare (Canada) Ltd.
⚠️ High Risk
FEI: 3002808377 • Aurora, Ontario • CANADA
FEI Number
3002808377
Location
Aurora, Ontario
Country
CANADAAddress
110 Industrial Pkwy N., Po Box 308 Stn Main, Aurora, Ontario, 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).
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.
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 |
|---|---|---|---|
| 11/7/2025 | 75OTVRESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES | Division of Southeast Imports (DSEI) | |
| 10/27/2022 | 66YCS99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2014 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 10/27/2014 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/6/2014 | 60CCS54BRIMONIDINE TARTRATE (ADRENERGIC) | 2880RXCOMPOUND | Division of Southeast Imports (DSEI) |
| 7/27/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/30/2006 | 61UCR99ANTI-ESTROGEN N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Piramal Healthcare (Canada) Ltd.'s FDA import refusal history?
Piramal Healthcare (Canada) Ltd. (FEI: 3002808377) has 7 FDA import refusal record(s) in our database, spanning from 8/30/2006 to 11/7/2025.
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. Piramal Healthcare (Canada) Ltd.'s FEI number is 3002808377.
What types of violations has Piramal Healthcare (Canada) Ltd. received?
Piramal Healthcare (Canada) Ltd. has been cited for 6 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 Piramal Healthcare (Canada) Ltd. come from?
All FDA import refusal data for Piramal Healthcare (Canada) Ltd. 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.