FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Sep 29, 2026
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on September 29, 2026, issued by the San Juan District Office, covering human drugs.
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ID · 331165e3-d75d-474c-a4da-c57b208dfea8
Inspection Facts
- Inspection number
- 1338220
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of Baxter Healthcare Corporation
13| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 3, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 1, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1240745 - 2024-07-19
- FDA Inspection 1149615 - 2021-07-30
- FDA Inspection 1075479 - 2018-12-21
- FDA Inspection 985599 - 2016-10-03
- FDA Inspection 925338 - 2015-05-01
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