Hospira Boulder, Inc.
Form 483 issued May 11, 2012 · Boulder, Colorado
- Inspection
- May 7 – May 11, 2012
- Investigators
- Erika V. Butler· Kimberley A. Hoefeo
- Observations
- 7
- Pages
- 7
- FEI number
- 3005231248
In short: On May 11, 2012, FDA issued a Form 483 with 7 observations to Hospira Boulder, Inc. in Boulder, Colorado (FEI 3005231248) after an inspection that ran May 7 – May 11, 2012. The investigators were Erika V. Butler and Kimberley A. Hoefeo. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your flilll has released product without the documentation of a robust process that yields a high…
- 02
A Field Alert Report was not submitted within three working days of receipt of infonnation concerning…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Written procedures are not established for the cleaning of equipment, including utensils used in the manufacture…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmHospira Boulder, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Erika V. Butler and Kimberley A. Hoefeo are named on this Form 483, for the inspection of May 7 – May 11, 2012. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran May 7 – May 11, 2012, and the Form 483 is dated May 11, 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.