Hospira, Inc.
Form 483 issued March 10, 2017 · Austin, Texas
- Inspection
- Feb 27 – Mar 10, 2017
- Investigators
- Margaret M. Annes· Shatina R. Alridge· Shawn E. Larson
- Observations
- 5
- Pages
- 6
- FEI number
- 1628454
In short: On March 10, 2017, FDA issued a Form 483 with 5 observations to Hospira, Inc. in Austin, Texas (FEI 1628454) after an inspection that ran Feb 27 – Mar 10, 2017. The investigators were Margaret M. Annes, Shatina R. Alridge and Shawn E. Larson. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 03
The sensitivity of test methods have not…
- 04
Deviations from written sampling plans and test procedures are…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmHospira, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Margaret M. Annes, Shatina R. Alridge and Shawn E. Larson are named on this Form 483, for the inspection of Feb 27 – Mar 10, 2017. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 10, 2017, and the Form 483 is dated March 10, 2017.
How do I get the full Form 483 for Hospira, Inc.?
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