Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-06-13.
At a glance
Inspections
7
Form 483s
5
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2013 – 13 Jun 2013 | Human Drugs | Clean | |
| 26 Jul 2012 | Not recorded | 483 | View 483 → |
| 9 Mar 2012 | Not recorded | 483 | View 483 → |
| 25 Jan 2011 | Not recorded | Clean | |
| 23 Feb 2010 | Not recorded | 483 | View 483 → |
| 29 Apr 2009 | Not recorded | 483 | View 483 → |
| 13 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Viviana Matta, Daphne Santiago, Jason F Chancey
26 Jul 2012
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Viviana Matta, Daphne Santiago, Jason F Chancey
26 Jul 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Viviana Matta, Daphne Santiago, Jason F Chancey
26 Jul 2012
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Viviana Matta, Daphne Santiago, Jason F Chancey
26 Jul 2012
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Viviana Matta, Daphne Santiago, Jason F Chancey
Investigators
FDA investigators tied to this site in the record.
Penny H Mccarver4 insp.
Viviana Matta2 insp.
Thomas R Berry2 insp.
Melanie M Walker1 insp.
Daphne Santiago1 insp.
Jason F Chancey1 insp.
Hai Lien T Phung1 insp.
Gabriel R Mclemore1 insp.
Randy L Clarida1 insp.
Ibad U Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hospira, Inc.'s 5 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