Company
IsraelLUMENIS, LTD., Yokne'Am Ilit, Israel – FDA Inspections
Inspection records and compliance data for LUMENIS, LTD. in Yokne'Am Ilit. 2 FDA inspections on record, 1 Form 483, last inspected February 02, 2017.
Company Profile
This profile covers LUMENIS, LTD. based in Yokne'Am Ilit, Israel.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 28, 2009. Last inspected February 2, 2017.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design plans- updated1 inspection
- Design validation - documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1001448 |
| May 28, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 587390 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LUMENIS, LTD.
FEI Number
3004135191
Address
Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, Israel
Country
Israel
ID: 29cce1e0-6fe1-4fd5-ba9d-8a08e35db7b6