Hospira Boulder, Inc.
Form 483 issued October 27, 2017 · McPherson, Kansas
- Inspection
- Oct 16 – Oct 27, 2017
- Investigators
- Michele Perry Williams· Robert J. Ham· Sarah E. Rhoades
- Observations
- 10
- Pages
- 8
- FEI number
- 1925262
In short: On October 27, 2017, FDA issued a Form 483 with 10 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Oct 16 – Oct 27, 2017. The investigators were Michele Perry Williams, Robert J. Ham and Sarah E. Rhoades. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 6 of 10 observations.
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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 03
Equipment used in the manufacture, processing, packing or. holding of drug products is not of appropriate…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Michele Perry Williams
22 documents · 2009–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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.?
Michele Perry Williams, Robert J. Ham and Sarah E. Rhoades are named on this Form 483, for the inspection of Oct 16 – Oct 27, 2017. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Oct 16 – Oct 27, 2017, and the Form 483 is dated October 27, 2017.
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.