Baxter Healthcare Corporation
Form 483 issued February 5, 2010 · Cleveland, Mississippi
- Inspection
- Jan 25 – Feb 5, 2010
- Investigator
- Marvin D. Jones
- Observations
- 4
- Pages
- 3
- FEI number
- 1019003
In short: On February 5, 2010, FDA issued a Form 483 with 4 observations to Baxter Healthcare Corporation in Cleveland, Mississippi (FEI 1019003) after an inspection that ran Jan 25 – Feb 5, 2010. The investigator was Marvin D. Jones. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures ,are not established which validate the performance of those manufacturing processes that may be…
- 02
Records are not kept for the maintenance…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
Products that do not conform to specifications…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmBaxter Healthcare Corporation history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Marvin D. Jones is named on this Form 483, for the inspection of Jan 25 – Feb 5, 2010. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Jan 25 – Feb 5, 2010, and the Form 483 is dated February 5, 2010.
How do I get the full Form 483 for Baxter Healthcare Corporation?
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.