Hospira, Inc.
Form 483 issued February 2, 2018 · Rocky Mount, North Carolina
- Inspection
- Jan 29 – Feb 2, 2018
- Investigators
- Bonita S. Chester· Claudette D. Brooks· Lesley K. Satterwhite
- Observations
- 4
- Pages
- 5
- FEI number
- 1021343
In short: On February 2, 2018, FDA issued a Form 483 with 4 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Jan 29 – Feb 2, 2018. The investigators were Bonita S. Chester, Claudette D. Brooks, Lesley K. Satterwhite, Sayeeda Hdabe and Tamara J. Henderson. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection of mechanical equipment is not performed according to a written program designed…
- 02
Test devices are deficient in that apparatus not meeting…
- 03
Deviations from written production and process control procedures…
- 04
Corrective and preventive action activities and/or results have…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
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 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Bonita S. Chester, Claudette D. Brooks, Lesley K. Satterwhite, Sayeeda Hdabe and Tamara J. Henderson are named on this Form 483, for the inspection of Jan 29 – Feb 2, 2018. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 2, 2018, and the Form 483 is dated February 2, 2018.
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.