Baxter International Inc.
Form 483 issued June 19, 2015 · Round Lake, Illinois
- Inspection
- May 27 – Jun 19, 2015
- Investigators
- Christopher D. Leach· David Gasparovich· Jesse A. Vazquez
- Observations
- 3
- Pages
- 3
- FEI number
- 1416980
In short: On June 19, 2015, FDA issued a Form 483 with 3 observations to Baxter International Inc. in Round Lake, Illinois (FEI 1416980) after an inspection that ran May 27 – Jun 19, 2015. The investigators were Christopher D. Leach, David Gasparovich and Jesse A. Vazquez. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Certain inspection, measuring, and test equipment is not suitable for its intended purposes and capable…
- 02
The device design was not correctly…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) 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 820.72
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter International Inc.?
FDA listed 3 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Baxter International Inc.?
Christopher D. Leach, David Gasparovich and Jesse A. Vazquez are named on this Form 483, for the inspection of May 27 – Jun 19, 2015. Each investigator has a profile showing what they cite most.
When was Baxter International Inc. inspected by FDA?
The inspection ran May 27 – Jun 19, 2015, and the Form 483 is dated June 19, 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.