Baxter International Inc.
Form 483 issued August 18, 2023 · Round Lake, Illinois
- Inspection
- Aug 14 – Aug 18, 2023
- Observations
- 1
- Pages
- 3
- FEI number
- 1416980
In short: On August 18, 2023, FDA issued a Form 483 with 1 observation to Baxter International Inc. in Round Lake, Illinois (FEI 1416980) after an inspection that ran Aug 14 – Aug 18, 2023. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
This inspection in context
Questions about this 483
What did FDA find at Baxter International Inc.?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
When was Baxter International Inc. inspected by FDA?
The inspection ran Aug 14 – Aug 18, 2023, and the Form 483 is dated August 18, 2023.
How do I get the full Form 483 for Baxter International Inc.?
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