FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Nov 16, 2012
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on November 16, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- November 16, 2012
- Product Type
- Veterinary
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ID · c40fbc45-11cb-4752-955d-2910463fcff8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 808425
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
10- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Baxter Healthcare Corporation
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2026 | Not classified | Atlanta District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1299166 - 2026-08-20
- FDA Inspection 1230544 - 2024-02-09
- FDA Inspection 1221559 - 2023-10-31
- FDA Inspection 1169330 - 2022-05-12
- FDA Inspection 1151566 - 2021-07-01
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