FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Mar 29, 2010
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on March 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 29, 2010
- Product Type
- Devices
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ID · 0f59faea-1f1a-4b56-a409-49ac5b7374b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657184
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.20(c)Management review accomplishment
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Baxter Healthcare Corporation
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 9, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 28, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 10, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1230610 - 2024-02-06
- FDA Inspection 1171501 - 2022-06-09
- FDA Inspection 1067768 - 2018-08-08
- FDA Inspection 988263 - 2016-09-28
- FDA Inspection 921291 - 2015-04-10
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