BAXALTA US INC.
Form 483 issued May 31, 2023 · LOS ANGELES, California
- Inspection
- May 22 – May 31, 2023
- Investigator
- Eileen A. Liu
- Observations
- 6
- Pages
- 9
- FEI number
- 2011021
In short: On May 31, 2023, FDA issued a Form 483 with 6 observations to BAXALTA US INC. in LOS ANGELES, California (FEI 2011021) after an inspection that ran May 22 – May 31, 2023. The investigator was Eileen A. Liu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's manufacturing deviation investigation and out of specification (OOS) result investigation…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Your firm's facility cleaning is deficient. ‘ A. Unsanitary conditions in room 932 of the (6)…
- 04
Your firm’s pre-viral and…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmBAXALTA US INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BAXALTA US INC.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected BAXALTA US INC.?
Eileen A. Liu is named on this Form 483, for the inspection of May 22 – May 31, 2023. Each investigator has a profile showing what they cite most.
When was BAXALTA US INC. inspected by FDA?
The inspection ran May 22 – May 31, 2023, and the Form 483 is dated May 31, 2023.
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.