Baxalta US Inc.
Form 483 issued April 7, 2022 · THOUSAND OAKS, California
- Inspection
- Mar 29 – Apr 7, 2022
- Investigators
- Lewis K. Antwi· Linda Thai
- Observations
- 2
- Pages
- 6
- FEI number
- 1000519965
In short: On April 7, 2022, FDA issued a Form 483 with 2 observations to Baxalta US Inc. in THOUSAND OAKS, California (FEI 1000519965) after an inspection that ran Mar 29 – Apr 7, 2022. The investigators were Lewis K. Antwi and Linda Thai. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.113(b)
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 production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Baxalta US Inc.?
Lewis K. Antwi and Linda Thai are named on this Form 483, for the inspection of Mar 29 – Apr 7, 2022. Each investigator has a profile showing what they cite most.
When was Baxalta US Inc. inspected by FDA?
The inspection ran Mar 29 – Apr 7, 2022, and the Form 483 is dated April 7, 2022.
How do I get the full Form 483 for Baxalta US 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.