FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Feb 9, 2024
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on February 9, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · af306a83-c8f6-4639-8e6c-5d8b74cc7791
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1230544
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Baxter Healthcare Corporation
10| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 26, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1221559 - 2023-10-31
- FDA Inspection 1169330 - 2022-05-12
- FDA Inspection 1151566 - 2021-07-01
- FDA Inspection 1031655 - 2017-11-17
- FDA Inspection 969544 - 2016-02-26
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