Baxter International Inc.
Form 483 issued July 7, 2015 · Round Lake, Illinois
- Inspection
- Jun 30 – Jul 7, 2015
- Investigator
- Simone E. Pitts
- Observations
- 5
- Pages
- 1
- FEI number
- 1416980
In short: On July 7, 2015, FDA issued a Form 483 with 5 observations to Baxter International Inc. in Round Lake, Illinois (FEI 1416980) after an inspection that ran Jun 30 – Jul 7, 2015. The investigator was Simone E. Pitts. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×) · 211.165 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) 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 211.192
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 quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Baxter International Inc.?
Simone E. Pitts is named on this Form 483, for the inspection of Jun 30 – Jul 7, 2015. Each investigator has a profile showing what they cite most.
When was Baxter International Inc. inspected by FDA?
The inspection ran Jun 30 – Jul 7, 2015, and the Form 483 is dated July 7, 2015.
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.