FDA Inspection
Abbott MedicalAbbott Medical – FDA Inspection, Aug 25, 2010
Record Details
This FDA Inspection record concerns Abbott Medical, with an inspection on August 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Medical
- Inspection Date
- August 25, 2010
- Product Type
- Devices
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ID · dcb272e0-d76d-4ab6-a920-d2553aede3d0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677604
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(c)Investigation of device failures
- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 11 citations.
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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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