Hospira Australia Pty, Limited
Form 483 issued September 2, 2022 · Mulgrave, Australia
- Inspection
- Aug 25 – Sep 2, 2022
- Investigator
- Michele L. Glendenning
- Observations
- 3
- Pages
- 3
- FEI number
- 3001174929
In short: On September 2, 2022, FDA issued a Form 483 with 3 observations to Hospira Australia Pty, Limited in Mulgrave, Victoria (FEI 3001174929) after an inspection that ran Aug 25 – Sep 2, 2022. The investigator was Michele L. Glendenning. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Written procedures are not always followed for the cleaning and maintenance of equipment, including utensils, used…
- 03
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmHospira Australia Pty, Limited history
All 2 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 Hospira Australia Pty, Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Hospira Australia Pty, Limited?
Michele L. Glendenning is named on this Form 483, for the inspection of Aug 25 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was Hospira Australia Pty, Limited inspected by FDA?
The inspection ran Aug 25 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
How do I get the full Form 483 for Hospira Australia Pty, Limited?
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.