FDA Inspection
Abbott MedicalAbbott Medical – FDA Inspection, May 2, 2011
Record Details
This FDA Inspection record concerns Abbott Medical, with an inspection on May 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Medical
- Inspection Date
- May 2, 2011
- Product Type
- Devices
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ID · f1380e7e-e1f0-43a6-9d3a-8cd3ab661b4f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 720384
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abbott Medical
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 3, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 15, 2017 | Not classified | Dallas District Office | |
| April 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abbott Medical
- FDA Inspection 1276721 - 2025-09-19
- FDA Inspection 1153679 - 2021-09-03
- FDA Inspection 1042259 - 2017-09-15
- FDA Inspection 1007916 - 2017-04-04
- FDA Inspection 985154 - 2016-08-18
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