Baxter Healthcare Corporation
Form 483 issued January 23, 2014 · Cleveland, Mississippi
- Inspection
- Jan 7 – Jan 23, 2014
- Investigators
- Marvin D. Jones· Thomas O. Morgan
- Observations
- 5
- Pages
- 2
- FEI number
- 1019003
In short: On January 23, 2014, FDA issued a Form 483 with 5 observations to Baxter Healthcare Corporation in Cleveland, Mississippi (FEI 1019003) after an inspection that ran Jan 7 – Jan 23, 2014. The investigators were Marvin D. Jones and Thomas O. Morgan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Routine calibration and inspection ofelectronic equipment is not performed according to a written program designed…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Marvin D. Jones and Thomas O. Morgan are named on this Form 483, for the inspection of Jan 7 – Jan 23, 2014. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Jan 7 – Jan 23, 2014, and the Form 483 is dated January 23, 2014.
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.