Company
United StatesLutech Industries Inc, Ronkonkoma, NY – FDA Inspections
Inspection records and compliance data for Lutech Industries Inc in Ronkonkoma, New York. 5 FDA inspections on record, 2 Form 483s, last inspected March 26, 2025.
Company Profile
This profile covers Lutech Industries Inc based in Ronkonkoma, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 18, 2013. Last inspected March 26, 2025.
Most cited issue areas
- Document change records, maintained.2 inspections
- Training records2 inspections
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1266521 |
| September 10, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1154488 |
| October 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028481 |
| July 17, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 941321 |
| October 18, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 852478 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lutech Industries Inc
FEI Number
3010023733
Address
105 Remington Blvd Ste C, Ronkonkoma, New York 11779, United States
Country
United States
ID: b0b8d4ca-8cb9-4b53-811a-b827525ebdcb