Hospira Boulder, Inc.
Form 483 issued August 30, 2007 · McPherson, Kansas
- Investigator
- Matthew R. Sleeter
- Observations
- 4
- Pages
- 3
- FEI number
- 1925262
In short: On August 30, 2007, FDA issued a Form 483 with 4 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262). The investigator was Matthew R. Sleeter. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Employees engaged in the manufacture of a drug product lack the training required to…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Matthew R. Sleeter
1 document · 2007
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Matthew R. Sleeter is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
This Form 483 is dated August 30, 2007.
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.