Hospira, Inc.
Form 483 issued September 24, 2015 · Rocky Mount, North Carolina
- Inspection
- Sep 14 – Sep 24, 2015
- Investigators
- Adam R. Cooke· Babatunde D. Babalola· Bonita S. Chester
- Observations
- 2
- Pages
- 2
- FEI number
- 1021343
In short: On September 24, 2015, FDA issued a Form 483 with 2 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Sep 14 – Sep 24, 2015. The investigators were Adam R. Cooke, Babatunde D. Babalola, Bonita S. Chester and Claudette D. Brooks. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
Observations span 1 system, led by capa.
Most cited: 21 CFR 820.198 (1×) · 21 CFR 211 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 0221 CFR 211
Observation 2: scanned text, readable in the full document.
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmHospira, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Adam R. Cooke, Babatunde D. Babalola, Bonita S. Chester and Claudette D. Brooks are named on this Form 483, for the inspection of Sep 14 – Sep 24, 2015. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Sep 14 – Sep 24, 2015, and the Form 483 is dated September 24, 2015.
How do I get the full Form 483 for Hospira, 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.