Hospira, Inc.
Form 483 issued April 27, 2011 · Austin, Texas
- Inspection
- Apr 4 – Apr 27, 2011
- Investigator
- Torrance J. Slayton
- Observations
- 11
- Pages
- 15
- FEI number
- 1628454
In short: On April 27, 2011, FDA issued a Form 483 with 11 observations to Hospira, Inc. in Austin, Texas (FEI 1628454) after an inspection that ran Apr 4 – Apr 27, 2011. The investigator was Torrance J. Slayton. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Drug products failing to meet established quality control…
- 03
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training…
- 04
Batch production and control records do not include the results of any investigation made into any…
This inspection in context
Torrance J. Slayton
5 documents · 2011–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Torrance J. Slayton is named on this Form 483, for the inspection of Apr 4 – Apr 27, 2011. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Apr 4 – Apr 27, 2011, and the Form 483 is dated April 27, 2011.
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.