FDA Inspection
American Thermal Instruments IncAmerican Thermal Instruments Inc – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns American Thermal Instruments Inc, with an inspection on March 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 6bba78df-1b1c-401b-a3b5-bab36124e770
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1043192
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Thermal Instruments Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Thermal Instruments Inc
- FDA Inspection 1220967 - 2023-10-20
- FDA Inspection 1164523 - 2022-03-14
- FDA Inspection 715596 - 2011-03-14
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.