Baxalta US Inc.
Form 483 issued July 1, 2021 · Social Circle, Georgia
- Inspection
- Jun 22 – Jul 1, 2021
- Observations
- 2
- Pages
- 3
- FEI number
- 3013980449
In short: On July 1, 2021, FDA issued a Form 483 with 2 observations to Baxalta US Inc. in Social Circle, Georgia (FEI 3013980449) after an inspection that ran Jun 22 – Jul 1, 2021. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete records of…
- 02
Procedures designed to prevent objectionable microorganisms in drug products are not…
This inspection in context
Questions about this 483
What did FDA find at Baxalta US Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
When was Baxalta US Inc. inspected by FDA?
The inspection ran Jun 22 – Jul 1, 2021, and the Form 483 is dated July 1, 2021.
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.