Prime Pacific Intern. Quality Products World Wide Ltd.
⚠️ Moderate Risk
FEI: 3002627520 • North Vancouver, British Columbia • CANADA
FEI Number
3002627520
Location
North Vancouver, British Columbia
Country
CANADAAddress
145 Riverside Dr, , North Vancouver, British Columbia, 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
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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/20/2008 | 78KPLSYSTEM, IRRIGATION, COLONIC | Cincinnati District Office (CIN-DO) | |
| 5/4/2005 | 78KPLSYSTEM, IRRIGATION, COLONIC | Cincinnati District Office (CIN-DO) | |
| 5/4/2005 | 78KPLSYSTEM, IRRIGATION, COLONIC | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Prime Pacific Intern. Quality Products World Wide Ltd.'s FDA import refusal history?
Prime Pacific Intern. Quality Products World Wide Ltd. (FEI: 3002627520) has 3 FDA import refusal record(s) in our database, spanning from 5/4/2005 to 6/20/2008.
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. Prime Pacific Intern. Quality Products World Wide Ltd.'s FEI number is 3002627520.
What types of violations has Prime Pacific Intern. Quality Products World Wide Ltd. received?
Prime Pacific Intern. Quality Products World Wide Ltd. 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 Prime Pacific Intern. Quality Products World Wide Ltd. come from?
All FDA import refusal data for Prime Pacific Intern. Quality Products World Wide 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.