BAXALTA US INC.
Form 483 issued September 15, 2022 · ROUND LAKE, Illinois
- Inspection
- Sep 8 – Sep 15, 2022
- Investigator
- Claire M. Minden
- Observations
- 3
- Pages
- 3
- FEI number
- 3012385969
In short: On September 15, 2022, FDA issued a Form 483 with 3 observations to BAXALTA US INC. in ROUND LAKE, Illinois (FEI 3012385969) after an inspection that ran Sep 8 – Sep 15, 2022. The investigator was Claire M. Minden. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observation- 01
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Establishment of the reliability of the supplier's report of analyses is deficient in that the test…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmBAXALTA US INC. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(6)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BAXALTA US INC.?
FDA listed 3 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected BAXALTA US INC.?
Claire M. Minden is named on this Form 483, for the inspection of Sep 8 – Sep 15, 2022. Each investigator has a profile showing what they cite most.
When was BAXALTA US INC. inspected by FDA?
The inspection ran Sep 8 – Sep 15, 2022, and the Form 483 is dated September 15, 2022.
How do I get the full Form 483 for BAXALTA US INC.?
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