Hospira Boulder, Inc.
Form 483 issued January 4, 2012 · Mcpherson, Kansas
- Inspection
- Nov 28, 2011 – Jan 4, 2012
- Investigators
- Michele L. Obert· Richard L. Rutherford· Tara L. Breckenridge
- Observations
- 6
- Pages
- 6
- FEI number
- 1925262
In short: On January 4, 2012, FDA issued a Form 483 with 6 observations to Hospira Boulder, Inc. in Mcpherson, Kansas (FEI 1925262) after an inspection that ran Nov 28, 2011 – Jan 4, 2012. The investigators were Michele L. Obert, Richard L. Rutherford and Tara L. Breckenridge. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Establishment of the reliability of the container supplier's report of analyses is deficient in that the…
- 04
Test devices are deficient in that instruments, apparatus, gauges, and recording devices not meeting…
This inspection in context
Michele L. Obert
6 documents · 2012–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmHospira Boulder, Inc. history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, 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 Boulder, Inc.?
Michele L. Obert, Richard L. Rutherford and Tara L. Breckenridge are named on this Form 483, for the inspection of Nov 28, 2011 – Jan 4, 2012. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Nov 28, 2011 – Jan 4, 2012, and the Form 483 is dated January 4, 2012.
How do I get the full Form 483 for Hospira Boulder, 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.