Baxalta US Inc.
Form 483 issued September 18, 2025 · Thou sand Oak s, California
- Inspection
- Sep 10 – Sep 18, 2025
- Investigators
- Alan L. Truong· Gene D. Arcy
- Observations
- 2
- Pages
- 4
- FEI number
- 1000519965
In short: On September 18, 2025, FDA issued a Form 483 with 2 observations to Baxalta US Inc. in Thou sand Oak s, California (FEI 1000519965) after an inspection that ran Sep 10 – Sep 18, 2025. The investigators were Alan L. Truong and Gene D. Arcy. Most observations concern cAPA and production; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
CAPA and production account for 2 of 2 observations.
Most cited: 21 CFR 803.50 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
The batch production and control records are deficient in that they do not include the identity…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmBaxalta US Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxalta US Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA and production. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Baxalta US Inc.?
Alan L. Truong and Gene D. Arcy are named on this Form 483, for the inspection of Sep 10 – Sep 18, 2025. Each investigator has a profile showing what they cite most.
When was Baxalta US Inc. inspected by FDA?
The inspection ran Sep 10 – Sep 18, 2025, and the Form 483 is dated September 18, 2025.
How do I get the full Form 483 for Baxalta US Inc.?
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