FDA Inspection
Amtai Medical Equipment, INCAmtai Medical Equipment, INC – FDA Inspection, Dec 6, 2024
Record Details
This FDA Inspection record concerns Amtai Medical Equipment, INC, with an inspection on December 6, 2024, issued by the Atlanta District Office, covering medical devices & rad health.
- Company
- Amtai Medical Equipment, INC
- Inspection Date
- December 6, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 99d15f5f-1c7c-4025-9568-fc40cfeea0d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256165
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amtai Medical Equipment, INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amtai Medical Equipment, INC
- FDA Inspection 1163282 - 2022-02-28
- FDA Inspection 1052245 - 2018-05-17
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.