Company
United StatesLenstec, Inc., St Petersburg, FL – FDA Inspections
Inspection records and compliance data for Lenstec, Inc. in St Petersburg, Florida. 3 FDA inspections on record, 1 Form 483, last inspected November 01, 2017.
Company Profile
This profile covers Lenstec, Inc. based in St Petersburg, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 24, 2012. Last inspected November 1, 2017.
Most cited issue areas
- Evaluation, timeliness, identification1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1030941 |
| July 18, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 841056 |
| January 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 761829 |
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
Lenstec, Inc.
FEI Number
3001659659
Address
1765 Commerce Ave N, St Petersburg, Florida 33716, United States
Country
United States
ID: 6890da6d-aeb3-4d21-8931-f7695e37342d