FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Nov 20, 2018
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on November 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c9feb4e5-d47a-4f96-b8b4-93ff0d859b9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072203
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Baxter Healthcare Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2025 | OAI | New Orleans District Office | Drug Quality Assurance |
| July 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1284446 - 2025-09-29
- FDA Inspection 1210861 - 2023-07-14
- FDA Inspection 1010362 - 2017-03-29
- FDA Inspection 983354 - 2016-04-27
- FDA Inspection 920235 - 2015-03-27
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