Hospira Boulder, Inc.
Form 483 issued July 13, 2012 · Lake Forest, Illinois
- Inspection
- Jun 19 – Jul 13, 2012
- Investigator
- Tonnie L. Carter
- Observations
- 10
- Pages
- 8
- FEI number
- 3005579246
In short: On July 13, 2012, FDA issued a Form 483 with 10 observations to Hospira Boulder, Inc. in Lake Forest, Illinois (FEI 3005579246) after an inspection that ran Jun 19 – Jul 13, 2012. The investigator was Tonnie L. Carter. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
7 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 contain in Block…
- 02
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Tonnie L. Carter
5 documents · 2008–2020
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Michigan.
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, production & process controls and records & documents. 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.?
Tonnie L. Carter is named on this Form 483, for the inspection of Jun 19 – Jul 13, 2012. Each investigator has a profile showing what they cite most.
When was Hospira Boulder, Inc. inspected by FDA?
The inspection ran Jun 19 – Jul 13, 2012, and the Form 483 is dated July 13, 2012.
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.