Planet Earth Logistics
⚠️ Moderate Risk
FEI: 3009333190 • Wakefield, West Yorkshire • UNITED KINGDOM
FEI Number
3009333190
Location
Wakefield, West Yorkshire
Country
UNITED KINGDOMAddress
PO Box 374, , Wakefield, West Yorkshire, United Kingdom
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2013 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/2/2013 | 85OHHBREAST PUMP KIT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/25/2012 | 85HGXPUMP, BREAST, POWERED | Los Angeles District Office (LOS-DO) | |
| 4/25/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 4/25/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Planet Earth Logistics's FDA import refusal history?
Planet Earth Logistics (FEI: 3009333190) has 5 FDA import refusal record(s) in our database, spanning from 4/25/2012 to 8/2/2013.
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. Planet Earth Logistics's FEI number is 3009333190.
What types of violations has Planet Earth Logistics received?
Planet Earth Logistics has been cited for 5 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 Planet Earth Logistics come from?
All FDA import refusal data for Planet Earth Logistics 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.