Hospira, Inc.
FDA inspection history in Austin, Texas, 2011 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2012: one Form 483; 2017: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–12Two Form 483s, at Austin, Texas.
- 2012The longest 483 on file: 19 observations over 14 pages at Austin, Texas.
- 2017One Form 483, at Austin, Texas.
- 2024One Form 483, at Austin, Texas.
Cited most
Across all Hospira observations on file
- 21 CFR 211.160General requirements7
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.166Stability testing3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures3
The complete Hospira file.
All 4 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
Austin, Texas
Four Form 483s · 2011 to 2024 · 45 observations
Latest: Form 483, Sep 20, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-20 | 483 Form 483 | Austin, Texas | 10 | $99 |
| 2017-03-10 | 483 Form 483 | Austin, Texas | 5 | $99 |
| 2012-08-24 | 483 Form 483 | Austin, Texas | 19 | $99 |
| 2011-04-27 | 483 Form 483 | Austin, Texas | 11 | $99 |
Investigators on these documents
Margaret M. Annes (2)Miguel A. Martinez (1)Santos E. Camara (1)Sharon K. Thoma (1)Shatina R. Alridge (1)Shawn E. Larson (1)Sina Shojaee (1)Lucas B. Leake (1)Torrance J. Slayton (1)
FEI number 1628454 · most recent document Sep 20, 2024
About Hospira, Inc.
How many FDA Form 483s has Hospira, Inc. received?
FDA Intel has 4 Form 483s on file for Hospira, Inc.; the most recent is dated Sep 20, 2024.
When was Hospira, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hospira, Inc. is a Form 483 dated Sep 20, 2024, for the site in Austin, Texas.
What did FDA cite at Hospira, Inc.?
The regulations cited most in the observations on file for Hospira, Inc. are 21 CFR 211.160 (General requirements), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.166 (Stability testing), 3 times.