Baxter Healthcare Pty Ltd.
Form 483 issued July 5, 2022 · Old Toongabbie, Australia
- Inspection
- Jun 27 – Jul 5, 2022
- Investigator
- Nicholas L. Hunt
- Observations
- 1
- Pages
- 1
- FEI number
- 1000440083
In short: On July 5, 2022, FDA issued a Form 483 with 1 observation to Baxter Healthcare Pty Ltd. in Old Toongabbie, NSW (FEI 1000440083) after an inspection that ran Jun 27 – Jul 5, 2022. The investigator was Nicholas L. Hunt. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmBaxter Healthcare Pty Ltd. history
The site's inspection history, in date order.
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 Baxter Healthcare Pty Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. 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 Baxter Healthcare Pty Ltd.?
Nicholas L. Hunt is named on this Form 483, for the inspection of Jun 27 – Jul 5, 2022. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Pty Ltd. inspected by FDA?
The inspection ran Jun 27 – Jul 5, 2022, and the Form 483 is dated July 5, 2022.
How do I get the full Form 483 for Baxter Healthcare Pty Ltd.?
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.