LGM Pharma (Yes Pharma) Ltd
⚠️ Moderate Risk
FEI: 3005264434 • Beit, Shemesh • ISRAEL
FEI Number
3005264434
Location
Beit, Shemesh
Country
ISRAELAddress
15 Hamelacha, St., Industrial Park Har Tuv A, , Beit, Shemesh, 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
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.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2012 | 65JCR18HYDROXYPROGESTERONE CAPROATE (PROGESTIN) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 3/18/2011 | 60XAS01DIHYDROERGOTAMINE MESYLATE (ANTI-ADRENERGIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 8/22/2008 | 63BDZ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 9/17/2007 | 56LAS72TYLOSIN TARTRATE (NON-CERTIFIABLE) | Seattle District Office (SEA-DO) | |
| 11/28/2006 | 60KAS99ANABOLIC, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/25/2006 | 63XIY99DIAGOSTIC AID (DRUGS) N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is LGM Pharma (Yes Pharma) Ltd's FDA import refusal history?
LGM Pharma (Yes Pharma) Ltd (FEI: 3005264434) has 6 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 5/11/2012.
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. LGM Pharma (Yes Pharma) Ltd's FEI number is 3005264434.
What types of violations has LGM Pharma (Yes Pharma) Ltd received?
LGM Pharma (Yes Pharma) Ltd has been cited for 3 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 LGM Pharma (Yes Pharma) Ltd come from?
All FDA import refusal data for LGM Pharma (Yes Pharma) 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.