Hospira Boulder, Inc.
Form 483 issued January 17, 2025 · McPherson, Kansas
- Inspection
- Jan 8 – Jan 17, 2025
- Investigators
- Chad W. Rice· Eric D. Bowles
- Observations
- 3
- Pages
- 5
- FEI number
- 1925262
In short: On January 17, 2025, FDA issued a Form 483 with 3 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Jan 8 – Jan 17, 2025. The investigators were Chad W. Rice and Eric D. Bowles. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Chad W. Rice
8 documents · 2023–2026
Cites 211.113(a) (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Chad W. Rice and Eric D. Bowles are named on this Form 483, for the inspection of Jan 8 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jan 8 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
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.