FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Sep 29, 2025
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on September 29, 2025, issued by the New Orleans District Office, covering human drugs.
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ID · bca90a34-d045-41e0-8c4a-1c7913aa79df
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1284446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Backup data not assured as exact and complete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Baxter Healthcare Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 27, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 27, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1210861 - 2023-07-14
- FDA Inspection 1072203 - 2018-11-20
- FDA Inspection 1010362 - 2017-03-29
- FDA Inspection 983354 - 2016-04-27
- FDA Inspection 920235 - 2015-03-27
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