FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Aug 20, 2026
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on August 20, 2026, issued by the Atlanta District Office, covering biologics.
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ID · 595951df-0e05-46ff-bfc1-f458d01d58e5
Inspection Facts
- Inspection number
- 1299166
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Baxter Healthcare Corporation
11| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2023 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 12, 2022 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 1, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1230544 - 2024-02-09
- FDA Inspection 1221559 - 2023-10-31
- FDA Inspection 1169330 - 2022-05-12
- FDA Inspection 1151566 - 2021-07-01
- FDA Inspection 1031655 - 2017-11-17
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