Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-07-14.
At a glance
Inspections
7
Form 483s
5
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jul 2016 – 14 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 20 Apr 2015 – 27 May 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Apr 2015 – 11 May 2015 | Medical Devices & Rad Health | 483 | On file |
| 22 Apr 2014 – 28 May 2014 | Medical Devices & Rad Health | 483 | On file |
| 29 Jan 2013 – 7 Feb 2013 | Medical Devices & Rad Health | 483 | On file |
| 13 Jul 2012 | Not recorded | 483 | On file |
| 20 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(h)
Incorrect translation to production specifications
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
Investigators
FDA investigators tied to this site in the record.
Jesse A Vazquez3 insp.
Sean T Creighton2 insp.
Phillip M Pontikos2 insp.
Rafael Padilla2 insp.
MDSAP PontikosP2 insp.
David J Gasparovich1 insp.
John M Seale1 insp.
Brian D Nicholson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Hospira Inc., A Pfizer Company's 5 Form 483s
Source PDFs 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