Hospira Boulder, Inc.
Form 483 issued August 8, 2018 · McPherson, Kansas
- Inspection
- Jul 23 – Aug 8, 2018
- Investigators
- Rita K. Kabaso· Robert J. Ham
- Observations
- 8
- Pages
- 10
- FEI number
- 1925262
In short: On August 8, 2018, FDA issued a Form 483 with 8 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Jul 23 – Aug 8, 2018. The investigators were Rita K. Kabaso and Robert J. Ham. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
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
Observation 2: scanned text, readable in the full document.
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Rita K. Kabaso and Robert J. Ham are named on this Form 483, for the inspection of Jul 23 – Aug 8, 2018. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jul 23 – Aug 8, 2018, and the Form 483 is dated August 8, 2018.
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.