Baxter International Inc.
Form 483 issued August 1, 2024 · Round Lake, Illinois
- Inspection
- Jul 23 – Aug 1, 2024
- Investigator
- Thispage Monica E. Murie
- Observations
- 5
- Pages
- 10
- FEI number
- 1416980
In short: On August 1, 2024, FDA issued a Form 483 with 5 observations to Baxter International Inc. in Round Lake, Illinois (FEI 1416980) after an inspection that ran Jul 23 – Aug 1, 2024. The investigator was Thispage Monica E. Murie. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The operations relating to the manufacture, processing and packing of cephalosporins are not performed in facilities…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training required to…
This inspection in context
Thispage Monica E. Murie
1 document · 2024
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Illinois.
The firmBaxter International Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter International Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Baxter International Inc.?
Thispage Monica E. Murie is named on this Form 483, for the inspection of Jul 23 – Aug 1, 2024. Each investigator has a profile showing what they cite most.
When was Baxter International Inc. inspected by FDA?
The inspection ran Jul 23 – Aug 1, 2024, and the Form 483 is dated August 1, 2024.
How do I get the full Form 483 for Baxter International Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.