Footcare Ltd.
⚠️ Moderate Risk
FEI: 3012106760 • Rishon Lezion, Hamerkaz • ISRAEL
FEI Number
3012106760
Location
Rishon Lezion, Hamerkaz
Country
ISRAELAddress
10 Hahsharat Hayesuv St, Bldg: Giron 2000, Hall No 114/68, Rishon Lezion, Hamerkaz, Israel
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 5/3/2024 | 89KNPORTHOSIS, CORRECTIVE SHOE | Division of Southeast Imports (DSEI) | |
| 12/9/2022 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Footcare Ltd.'s FDA import refusal history?
Footcare Ltd. (FEI: 3012106760) has 8 FDA import refusal record(s) in our database, spanning from 12/9/2022 to 5/22/2024.
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. Footcare Ltd.'s FEI number is 3012106760.
What types of violations has Footcare Ltd. received?
Footcare Ltd. has been cited for 2 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 Footcare Ltd. come from?
All FDA import refusal data for Footcare 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.