Hospira Boulder, Inc.
Form 483 issued May 27, 2015 · Lake Forest, Illinois
- Inspection
- Apr 20 – May 27, 2015
- Investigators
- Phillip M. Pontikos· Rafael Padilla
- Observations
- 4
- Pages
- 6
- FEI number
- 3005579246
In short: On May 27, 2015, FDA issued a Form 483 with 4 observations to Hospira Boulder, Inc. in Lake Forest, Illinois (FEI 3005579246) after an inspection that ran Apr 20 – May 27, 2015. The investigators were Phillip M. Pontikos and Rafael Padilla. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
3 of 4 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (3×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design validation have…
- 02
The device design was not correctly…
- 03
Procedures for design change have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Phillip M. Pontikos
5 documents · 2015–2019
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in France.
The firmHospira Boulder, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 4 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Phillip M. Pontikos and Rafael Padilla are named on this Form 483, for the inspection of Apr 20 – May 27, 2015. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Apr 20 – May 27, 2015, and the Form 483 is dated May 27, 2015.
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.