Company
United StatesAmerican Thermal Instruments Inc, Moraine, OH – FDA Inspections
Inspection records and compliance data for American Thermal Instruments Inc in Moraine, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected October 20, 2023.
Company Profile
This profile covers American Thermal Instruments Inc based in Moraine, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 14, 2011. Last inspected October 20, 2023.
Most cited issue areas
- Production processes2 inspections
- Design input - Lack of or inadequate procedures1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 20, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1220967 |
| March 14, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1164523 |
| March 1, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1043192 |
| March 14, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 715596 |
FDA documents
Form 483s (1)
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
American Thermal Instruments Inc
FEI Number
1526410
Address
2400 E River Rd, Moraine, Ohio 45439, United States
Country
United States
ID: fc83d7d9-be98-4084-8bfb-be7dcc903bd9