FDA Inspection
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA Inspection, Jun 27, 2012
Record Details
This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on June 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 27, 2012
- Product Type
- Drugs
View Company Profile
ID · a52492e5-c003-4f6b-aa7e-b0624d316421
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 789123
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Baxter Healthcare Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2025 | OAI | New Orleans District Office | Drug Quality Assurance |
| July 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 27, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Baxter Healthcare Corporation
- FDA Inspection 1284446 - 2025-09-29
- FDA Inspection 1210861 - 2023-07-14
- FDA Inspection 1072203 - 2018-11-20
- FDA Inspection 1010362 - 2017-03-29
- FDA Inspection 983354 - 2016-04-27
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.