Hospira Boulder, Inc.
Form 483 issued February 7, 2013 · Lake Forest, Illinois
- Inspection
- Jan 29 – Feb 7, 2013
- Investigators
- Jesse A. Vazquez· Sean T. Creighton
- Observations
- 10
- Pages
- 9
- FEI number
- 3005579246
In short: On February 7, 2013, FDA issued a Form 483 with 10 observations to Hospira Boulder, Inc. in Lake Forest, Illinois (FEI 3005579246) after an inspection that ran Jan 29 – Feb 7, 2013. The investigators were Jesse A. Vazquez and Sean T. Creighton. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
6 of 10 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (3×) · 820.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block…
- 02
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated…
- 03
Procedures for design control…
- 04
Procedures for design change have…
This inspection in context
Jesse A. Vazquez
4 documents · 2013–2019
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
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 820.100
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 cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Hospira Boulder, Inc.?
Jesse A. Vazquez and Sean T. Creighton are named on this Form 483, for the inspection of Jan 29 – Feb 7, 2013. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 7, 2013, and the Form 483 is dated February 7, 2013.
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.