FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Aug 26, 2010
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on August 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 26, 2010
- Product Type
- Drugs
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ID · d08a2b74-2de1-4000-88a5-ebf06bc955e7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 679626
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Written calibration procedures
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Other FDA inspections of Baxter Healthcare Corporation
13| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2026 | Not classified | San Juan District Office | Drug Quality Assurance |
| 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 |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1338220 - 2026-09-29
- FDA Inspection 1240745 - 2024-07-19
- FDA Inspection 1149615 - 2021-07-30
- FDA Inspection 1075479 - 2018-12-21
- FDA Inspection 985599 - 2016-10-03
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