Hospira Australia Pty, Limited
FDA inspection history in Mulgrave, Australia, 2014 to 2022
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One warning letter, at Mulgrave, Australia.
- 2022One Form 483, at Mulgrave, Australia.
Cited most
Across all Hospira Australia Pty, Limited observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Hospira Australia Pty, Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mulgrave, Australia
One Form 483 and one warning letter · 2014 to 2022 · 3 observations
Latest: Form 483, Sep 2, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-02 | 483 Form 483 | Mulgrave, Australia | 3 | $99 |
| 2014-09-26 | Warning letter Warning letter | Mulgrave, Australia | — | $99 |
Investigators on these documents
FEI number 3001174929 · most recent document Sep 2, 2022
About Hospira Australia Pty, Limited
How many FDA Form 483s has Hospira Australia Pty, Limited received?
FDA Intel has 1 Form 483 on file for Hospira Australia Pty, Limited; the most recent is dated Sep 2, 2022.
When was Hospira Australia Pty, Limited last inspected by FDA?
The most recent FDA inspection document on file for Hospira Australia Pty, Limited is a Form 483 dated Sep 2, 2022, for the site in Mulgrave, Australia.
What did FDA cite at Hospira Australia Pty, Limited?
The regulations cited most in the observations on file for Hospira Australia Pty, Limited are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.
Has Hospira Australia Pty, Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hospira Australia Pty, Limited; the most recent is dated Sep 26, 2014.