Hospira Boulder, Inc.
FDA inspection history across 2 sites, 2002 to 2025
- 11
- Form 483s
Every document, by year
- Form 483
2002: one Form 483; 2007: one Form 483; 2010: one Form 483; 2012: two Form 483s; 2016: one Form 483; 2017: one Form 483; 2018: one Form 483; 2020: one Form 483; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One Form 483, at McPherson, Kansas.
- 2007One Form 483, at McPherson, Kansas.
- 2010–12Three Form 483s, at McPherson, Kansas and Mcpherson, Kansas.
- 2016–20Four Form 483s, at McPherson, Kansas and Mcpherson, Kansas.
- 2016The longest 483 on file: 14 observations over 21 pages at McPherson, Kansas.
- 2023–25Two Form 483s, at McPherson, Kansas.
Cited most
Across all Hospira Boulder observations on file
- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.192Production record review9
- 21 CFR 211.110Sampling and testing of in-process materials and drug products5
- 21 CFR 211.160General requirements5
- 21 CFR 211.100Written procedures; deviations4
The complete Hospira Boulder file.
All 11 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
McPherson, Kansas
Nine Form 483s · 2002 to 2025 · 48 observations
Latest: Form 483, Jan 17, 2025 →Mcpherson, Kansas
Two Form 483s · 2012 to 2020 · 16 observations
Latest: Form 483, Jan 17, 2020 →
Documents
11 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-17 | 483 Form 483 | McPherson, Kansas | 3 | $99 |
| 2023-06-30 | 483 Form 483 | McPherson, Kansas | — | $99 |
| 2020-01-17 | 483 Form 483 | Mcpherson, Kansas | 10 | $99 |
| 2018-08-08 | 483 Form 483 | McPherson, Kansas | 8 | $99 |
| 2017-10-27 | 483 Form 483 | McPherson, Kansas | 10 | $99 |
| 2016-06-08 | 483 Form 483 | McPherson, Kansas | 14 | $99 |
| 2012-10-24 | 483 Form 483 | McPherson, Kansas | 2 | $99 |
| 2012-01-04 | 483 Form 483 | Mcpherson, Kansas | 6 | $99 |
| 2010-02-03 | 483 Form 483 | McPherson, Kansas | 6 | $99 |
| 2007-08-30 | 483 Form 483 | McPherson, Kansas | 4 | $99 |
| 2002-09-12 | 483 Form 483 | McPherson, Kansas | 1 | $99 |
Investigators on these documents
Robert J. Ham (2)Michele Perry Williams (2)Chad W. Rice (1)Damaris Y. Hernandez (1)Doan N. Singh (1)Eric D. Bowles (1)Jazmine N. Still (1)Matthew R. Sleeter (1)Michele L. Obert (1)Richard L. Rutherford (1)Rita K. Kabaso (1)Sarah E. Rhoades (1)
FEI number 1925262 · most recent document Jan 17, 2025
About Hospira Boulder, Inc.
How many FDA Form 483s has Hospira Boulder, Inc. received?
FDA Intel has 11 Form 483s on file for Hospira Boulder, Inc.; the most recent is dated Jan 17, 2025.
When was Hospira Boulder, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hospira Boulder, Inc. is a Form 483 dated Jan 17, 2025, for the site in McPherson, Kansas.
What did FDA cite at Hospira Boulder, Inc.?
The regulations cited most in the observations on file for Hospira Boulder, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 11 times; 21 CFR 211.192 (Production record review), 9 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 5 times.