Hospira Boulder, Inc.
Form 483 issued January 17, 2020 · Mcpherson, Kansas
- Inspection
- Dec 9, 2019 – Jan 17, 2020
- Investigators
- Jazmine N. Still· Scott A. Golladay· Simone E. Pitts
- Observations
- 10
- Pages
- 13
- FEI number
- 1925262
In short: On January 17, 2020, FDA issued a Form 483 with 10 observations to Hospira Boulder, Inc. in Mcpherson, Kansas (FEI 1925262) after an inspection that ran Dec 9, 2019 – Jan 17, 2020. The investigators were Jazmine N. Still, Scott A. Golladay and Simone E. Pitts. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 8 of 10 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Jazmine N. Still, Scott A. Golladay and Simone E. Pitts are named on this Form 483, for the inspection of Dec 9, 2019 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Dec 9, 2019 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
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.