FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Apr 22, 2009
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on April 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 22, 2009
- Product Type
- Devices
View Company Profile
ID · d05c94fe-12d0-4670-a002-b53d794a6177
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 577601
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.20Management responsibility
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.181(a)DMR device specifications
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.