Company
United StatesMinaris Medical America, Inc., Mountain View, CA – FDA Inspections
Inspection records and compliance data for Minaris Medical America, Inc. in Mountain View, California. 5 FDA inspections on record, last inspected December 16, 2022.
Company Profile
This profile covers Minaris Medical America, Inc. based in Mountain View, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 6, 2010. Last inspected December 16, 2022.
Most cited issue areas
- Lack of or inadequate In-process acceptance procedures1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
- Report of risk to health1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1194876 |
| June 6, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1097911 |
| April 21, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 923042 |
| July 11, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 792552 |
| August 6, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 675121 |
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
Minaris Medical America, Inc.
FEI Number
2936856
Address
630 Clyde Ct, Mountain View, California 94043, United States
Country
United States
ID: b1e8ef36-a25b-4de3-a82f-bb447850c207