Pharmetics Incorporated Jarvis Street Pharma
⚠️ Moderate Risk
FEI: 3002892018 • Fort Erie, Ontario • CANADA
FEI Number
3002892018
Location
Fort Erie, Ontario
Country
CANADAAddress
333 Jarvis St, , Fort Erie, 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
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2008 | 54FYY12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 218LIST INGRE | New Orleans District Office (NOL-DO) |
| 8/16/2005 | 64XAL99KERATOLYTIC N.E.C. | New York District Office (NYK-DO) | |
| 11/22/2004 | 80MMSLUBRICANT, VAGINAL, PATIENT | New Orleans District Office (NOL-DO) | |
| 10/3/2001 | 54AEA99VITAMIN, N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmetics Incorporated Jarvis Street Pharma's FDA import refusal history?
Pharmetics Incorporated Jarvis Street Pharma (FEI: 3002892018) has 4 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 10/2/2008.
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. Pharmetics Incorporated Jarvis Street Pharma's FEI number is 3002892018.
What types of violations has Pharmetics Incorporated Jarvis Street Pharma received?
Pharmetics Incorporated Jarvis Street Pharma 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 Pharmetics Incorporated Jarvis Street Pharma come from?
All FDA import refusal data for Pharmetics Incorporated Jarvis Street Pharma 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.