FDA Inspection
AbbottAbbott – FDA Inspection, Jun 28, 2024
Record Details
This FDA Inspection record concerns Abbott, with an inspection on June 28, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9ceb45b5-fdaa-440e-bcef-799bc0892c30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228934
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.46(a)Device return/disposal by non-compliant investigator
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Abbott
14| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 22, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 26, 2018 | Not classified | Minneapolis District Office | |
| April 25, 2018 | Not classified | Minneapolis District Office | |
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Abbott
- FDA Inspection 1117585 - 2020-01-10
- FDA Inspection 1057461 - 2018-06-22
- FDA Inspection 1071075 - 2018-04-26
- FDA Inspection 1071072 - 2018-04-25
- FDA Inspection 1055664 - 2018-02-01
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