Hospira Boulder, Inc.
Form 483 issued June 21, 2011 · Boulder, Colorado
- Inspection
- Jun 14 – Jun 21, 2011
- Investigators
- Erika V. Butler· Kimberley A. Hoefeo· Zachery L. Miller
- Observations
- 5
- Pages
- 3
- FEI number
- 3005231248
In short: On June 21, 2011, FDA issued a Form 483 with 5 observations to Hospira Boulder, Inc. in Boulder, Colorado (FEI 3005231248) after an inspection that ran Jun 14 – Jun 21, 2011. The investigators were Erika V. Butler, Kimberley A. Hoefeo and Zachery L. Miller. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.100 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The finn has released product without the documentation of a robust process that yields a high…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
Written procedures are not established for the cleaning of equipment, including utensils, used in the manufacture…
- 04
Lack of adequate written procedures for obtaining a…
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Erika V. Butler, Kimberley A. Hoefeo and Zachery L. Miller are named on this Form 483, for the inspection of Jun 14 – Jun 21, 2011. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 21, 2011, and the Form 483 is dated June 21, 2011.
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.