Optimum Compounding Pharmacy
⚠️ High Risk
FEI: 3003764315 • Richmond Hill, Ontario • CANADA
FEI Number
3003764315
Location
Richmond Hill, Ontario
Country
CANADAAddress
10171 Yonge St, , Richmond Hill, 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).
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 |
|---|---|---|---|
| 11/18/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/15/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/15/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66BCY99STIMULANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/11/2002 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | Detroit District Office (DET-DO) | |
| 9/6/2002 | 65PCC02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/5/2002 | 61NDA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Optimum Compounding Pharmacy's FDA import refusal history?
Optimum Compounding Pharmacy (FEI: 3003764315) has 47 FDA import refusal record(s) in our database, spanning from 9/5/2002 to 11/18/2002.
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. Optimum Compounding Pharmacy's FEI number is 3003764315.
What types of violations has Optimum Compounding Pharmacy received?
Optimum Compounding Pharmacy has been cited for 3 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 Optimum Compounding Pharmacy come from?
All FDA import refusal data for Optimum Compounding 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.