Company
United StatesAlltech Medical Systems America Inc, Solon, OH – FDA Inspections
Inspection records and compliance data for Alltech Medical Systems America Inc in Solon, Ohio. 3 FDA inspections on record, 1 Form 483, last inspected July 29, 2019.
Company Profile
This profile covers Alltech Medical Systems America Inc based in Solon, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 17, 2009. Last inspected July 29, 2019.
Most cited issue areas
- Design history file1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1097831 |
| March 21, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 827215 |
| June 17, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 589973 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alltech Medical Systems America Inc
FEI Number
3007138967
Address
28900 Fountain Pkwy Ste A, Solon, Ohio 44139, United States
Country
United States
ID: 239def2e-4814-4f48-91a6-c5498cc93e40