Hospira, Inc.
Form 483 issued August 24, 2012 · Austin, Texas
- Inspection
- Jul 30 – Aug 24, 2012
- Investigators
- Lucas B. Leake· Margaret M. Annes· Sharon K. Thoma
- Observations
- 19
- Pages
- 14
- FEI number
- 1628454
In short: On August 24, 2012, FDA issued a Form 483 with 19 observations to Hospira, Inc. in Austin, Texas (FEI 1628454) after an inspection that ran Jul 30 – Aug 24, 2012. The investigators were Lucas B. Leake, Margaret M. Annes, Sharon K. Thoma and Sina Shojaee. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An NDA-Field Alert Report was not submitted witbin three working days of receipt ofinformation concerning significant…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Lucas B. Leake
8 documents · 2012–2019
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 314.81(b)(1)(ii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 19 observations on this Form 483, mostly about quality system, laboratory controls and materials. 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.?
Lucas B. Leake, Margaret M. Annes, Sharon K. Thoma and Sina Shojaee are named on this Form 483, for the inspection of Jul 30 – Aug 24, 2012. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 24, 2012, and the Form 483 is dated August 24, 2012.
How do I get the full Form 483 for Hospira, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.