Hospira Boulder, Inc.
Form 483 issued June 8, 2016 · McPherson, Kansas
- Inspection
- Jun 8, 2016
- Investigators
- Brett R. Havranek· Carl A. Huffman· Michele Perry Williams
- Observations
- 14
- Pages
- 21
- FEI number
- 1925262
In short: On June 8, 2016, FDA issued a Form 483 with 14 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Jun 8, 2016. The investigators were Brett R. Havranek, Carl A. Huffman, Michele Perry Williams and Shafiq S. Ahadi. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.192 (3×) · 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
An FDA Field Alert was not submitted within three working days of receipt of information concerning…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 14 observations on this Form 483, mostly about production, quality system 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.?
Brett R. Havranek, Carl A. Huffman, Michele Perry Williams and Shafiq S. Ahadi are named on this Form 483, for the inspection of Jun 8, 2016. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jun 8, 2016, and the Form 483 is dated June 8, 2016.
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.