Pollogen Ltd
⚠️ Moderate Risk
FEI: 3008753275 • Tel Aviv • ISRAEL
FEI Number
3008753275
Location
Tel Aviv
Country
ISRAELAddress
6 Kaufman Street, , Tel Aviv, , 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2020 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 5/21/2019 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 8/31/2018 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | Division of Southwest Imports (DSWI) | |
| 11/16/2011 | 79ORKLASER ASSISTED LIPOLYSIS | New Orleans District Office (NOL-DO) | |
| 11/16/2011 | 79ORKLASER ASSISTED LIPOLYSIS | New Orleans District Office (NOL-DO) | |
| 10/27/2011 | 79GFDDERMATOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pollogen Ltd's FDA import refusal history?
Pollogen Ltd (FEI: 3008753275) has 6 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 7/28/2020.
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. Pollogen Ltd's FEI number is 3008753275.
What types of violations has Pollogen Ltd received?
Pollogen Ltd 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 Pollogen Ltd come from?
All FDA import refusal data for Pollogen 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.