Company
United StatesAmerican Medical Systems Innovations, San Jose, CA – FDA Inspections
Inspection records and compliance data for American Medical Systems Innovations in San Jose, California. 3 FDA inspections on record, 1 Form 483, last inspected February 27, 2018.
Company Profile
This profile covers American Medical Systems Innovations based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 21, 2012. Last inspected February 27, 2018.
Most cited issue areas
- Report of Death or Serious Injury1 inspection
- Submission of Supplement to Individual Report Within One Month1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1042434 |
| April 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 921183 |
| December 21, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 811690 |
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
American Medical Systems Innovations
FEI Number
2937094
Address
3070 Orchard Dr, San Jose, California 95134, United States
Country
United States
ID: 4a631a8e-6036-407c-a4be-c3170f1e1549