Baxalta US Inc.
Form 483 issued January 17, 2020 · THOUSAND OAKS, California
- Inspection
- Jan 8 – Jan 17, 2020
- Investigators
- Eileen A. Liu· S. Sef Svetlana Shestopal
- Observations
- 11
- Pages
- 11
- FEI number
- 1000519965
In short: On January 17, 2020, FDA issued a Form 483 with 11 observations to Baxalta US Inc. in THOUSAND OAKS, California (FEI 1000519965) after an inspection that ran Jan 8 – Jan 17, 2020. The investigators were Eileen A. Liu and S. Sef Svetlana Shestopal. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 02
There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or…
- 03
Control procedures are not established which monitors the output and validated performance of those manufacturing processes…
- 04
Procedures designed to prevent contamination of drug products purporting to be sterile did not include adequate…
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
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 11 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 and S. Sef Svetlana Shestopal are named on this Form 483, for the inspection of Jan 8 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Baxalta US Inc. inspected by FDA?
The inspection ran Jan 8 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
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.