Company
United StatesBaxter Healthcare Corporation - Inspection Records
Inspection records and compliance data for Baxter Healthcare Corporation in Jayuya, Puerto Rico. 13 FDA inspections on record (5 OAI), last inspected July 19, 2024.
Company Profile
This profile covers Baxter Healthcare Corporation based in Jayuya, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 5
- VAI
- 3
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected April 17, 2009. Last inspected July 19, 2024.
Most cited issue areas
- Contamination, chemical or physical change, deterioration4 inspections
- Procedures not in writing, fully followed4 inspections
- Control procedures to monitor and validate performance3 inspections
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 1, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (14)
483 - Baxter Healthcare Corporation - 2024-07-19
483
483 - Baxter Healthcare Corporation - 2024-07-19
483
FDA Inspection 1240745 - Baxter Healthcare Corporation - 2024-07-19
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FDA Inspection 1149615 - Baxter Healthcare Corporation - 2021-07-30
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EIR - Baxter Healthcare Corporation - 2018-12-21
EIR
483 - Baxter Healthcare Corporation - 2018-12-21
483
FDA Inspection 1075479 - Baxter Healthcare Corporation - 2018-12-21
fda_inspection
FDA Inspection 985599 - Baxter Healthcare Corporation - 2016-10-03
fda_inspection
FDA Inspection 925338 - Baxter Healthcare Corporation - 2015-05-01
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FDA Inspection 864714 - Baxter Healthcare Corporation - 2014-02-11
fda_inspection
FDA Inspection 850188 - Baxter Healthcare Corporation - 2013-09-26
fda_inspection
FDA Inspection 850188 - Baxter Healthcare Corporation - 2013-09-26
fda_inspection
FDA Inspection 832023 - Baxter Healthcare Corporation - 2013-04-19
fda_inspection
FDA Inspection 752297 - Baxter Healthcare Corporation - 2011-11-03
fda_inspection
... and 4 more documents
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Search nearby companiesCompany Information
Name
Baxter Healthcare Corporation
FEI Number
2618677
State
Puerto Rico
City
Jayuya
ID: 0296844d-4369-423c-824a-f7d71344ec07