FDA Inspection
Lenstec, Inc.Lenstec, Inc. – FDA Inspection, Nov 1, 2017
Record Details
This FDA Inspection record concerns Lenstec, Inc., with an inspection on November 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c4418754-4dcb-4145-8ddc-c62f97eda9a7
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1030941
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lenstec, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lenstec, Inc.
- FDA Inspection 841056 - 2013-07-18
- FDA Inspection 761829 - 2012-01-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.