Hospira Boulder, Inc.
Form 483 issued February 3, 2010 · McPherson, Kansas
- Inspection
- Mar 2 – Mar 10, 2026
- Investigators
- Doan N. Singh· Wayne Seifert
- Observations
- 6
- Pages
- 7
- FEI number
- 1925262
In short: On February 3, 2010, FDA issued a Form 483 with 6 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Mar 2 – Mar 10, 2026. The investigators were Doan N. Singh and Wayne Seifert. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish process controls designed to assure that the drug products manufactured have the identity…
- 02
Equipment and facilities in (b)(4) drug product manufacture are not…
- 03
Failure to maintain equipment and facilities in a good state of repair in…
- 04
Procedures in drug product…
This inspection in context
Doan N. Singh
2 documents · 2010–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.100
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 facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Doan N. Singh and Wayne Seifert are named on this Form 483, for the inspection of Mar 2 – Mar 10, 2026. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2026, and the Form 483 is dated February 3, 2010.
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.