Overview
- 19 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-07.
At a glance
Inspections
19
Form 483s
11
EIRs
6
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jan 2025 – 7 Feb 2025 | Human Drugs | Clean | |
| 6 Nov 2023 – 14 Nov 2023 | Human Drugs | 483 | View 483 → |
| 12 Nov 2019 – 21 Nov 2019 | Human Drugs | 483 | View 483 → |
| 29 Jan 2018 – 2 Feb 2018 | Human Drugs | 483 | View 483 → |
| 23 May 2016 – 26 May 2016 | Human Drugs | Clean | |
| 14 Sep 2015 – 24 Sep 2015 | Human Drugs | 483 | On file |
| 3 Jun 2014 – 13 Jun 2014 | Human Drugs | Clean | |
| 30 Sep 2013 – 15 Nov 2013 | Medical Devices & Rad Health | WL | On file |
| 12 Feb 2013 – 1 Mar 2013 | Human Drugs | 483 | View 483 → |
| 4 Aug 2011 | Not recorded | 483 | On file |
| 17 Jun 2011 | Not recorded | 483 | View 483 → |
| 4 Jun 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Adam R Cooke, Sonya M Edmonds, Gideon N Esuzor
21 Nov 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Adam R Cooke, Sonya M Edmonds, Gideon N Esuzor
21 Nov 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Adam R Cooke, Sonya M Edmonds, Gideon N Esuzor
2 Feb 2018
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Bonita S Chester, Sayeeda Hdabe, Claudette D Brooks, Tamara J Henderson, Lesley K Satterwhite
Investigators
FDA investigators tied to this site in the record.
Claudette D Brooks4 insp.
Penny H Mccarver4 insp.
Adam R Cooke3 insp.
Jason F Chancey3 insp.
Sonya M Edmonds2 insp.
Bonita S Chester2 insp.
Sayeeda Hdabe2 insp.
Viviana Matta2 insp.
Tammara A Stephens2 insp.
Thomas R Berry2 insp.
Walden H Lee1 insp.
Marian E Ramirez1 insp.
Damaris Y Hernandez1 insp.
Saundrea A Munroe1 insp.
Gideon N Esuzor1 insp.
Tamara J Henderson1 insp.
Lesley K Satterwhite1 insp.
Seneca D Toms1 insp.
Babatunde D Babalola1 insp.
Joseph F Owens1 insp.
Xiomara Copeland1 insp.
Katrina B Sloan1 insp.
Thomas J Arista1 insp.
Daphne Santiago1 insp.
Denise M Digiulio1 insp.
Melanie M Walker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hospira, Inc.'s 11 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat