FDA Inspection
Amtai Medical Equipment, INCAmtai Medical Equipment, INC – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Amtai Medical Equipment, INC, with an inspection on May 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cea3dc0a-cc06-4ee1-9b16-da9b420800b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052245
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Lack of procedures, or not maintained
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Other FDA inspections of Amtai Medical Equipment, INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2024 | VAI | Atlanta District Office | Compliance: Medical Devices |
| February 28, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amtai Medical Equipment, INC
- FDA Inspection 1256165 - 2024-12-06
- FDA Inspection 1163282 - 2022-02-28
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